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Elasty D

Elasty® · DongBang Medical

Elasty D

Sterile, resorbable viscoelastic dermal filler of cross-linked hyaluronic acid (24 mg/ml) for injection into the deep dermis. According to the manufacturer's instructions for use, the product is intended to replace volume defects, correct HIV-induced lipoatrophy and improve facial contour deformities caused by tissue loss due to accident or disease.

  • 24 mg/ml HA
  • Deep dermis
  • 2 × 1 ml

Key facts

  • Cross-linked hyaluronic acid of non-animal origin, produced by bacterial fermentation and sterilised with moist heat.
  • According to the manufacturer's instructions for use, the product remains implanted in skin tissue for at least 6 months (preclinical evaluation) and is expected to be fully degraded after 1 year.
  • Elasty D, F and G are different models in the range and share the same instructions for use.

CE-marked medical device (CE 2195). To be used only by a physician trained in the use of the product. Manufacturer: DongBang Medical Co., Ltd., South Korea.

See the full Elasty range →

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  • Norwegian warehouse
  • 1 to 2 day delivery
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Description

What it is

Elasty D is a sterile, resorbable viscoelastic dermal filler of cross-linked hyaluronic acid (24 mg/ml) from DongBang Medical, supplied in a pre-filled single-use glass syringe.

Intended use

According to the manufacturer's instructions for use, the product is injected into the deep dermis to replace volume defects, correct HIV-induced lipoatrophy and improve facial contour deformities (e.g. asymmetry) caused by tissue loss due to accident or disease. The instructions for use do not specify different areas of use for models D, F and G.

Important precautions

Injection in the area around the eyes is not recommended, because the skin is thin and the product can easily enter blood vessels (risk of serious adverse effects, including blindness). There are no established standards for safety and efficacy in lip augmentation. Do not inject into blood vessels, bone, tendons or muscles.

Documentation and traceability

CE-marked medical device (CE 2195). Manufacturer: DongBang Medical Co., Ltd., South Korea. Authorised representative in the EU: Meridius Medical Europe Ltd., Ireland. Instructions for use are attached.

Ingredients and composition

Composition: Cross-linked hyaluronic acid gel 24 mg/ml, of non-animal origin. One syringe contains 1.0 ml.

Directions and protocol

According to the manufacturer's instructions for use: clean the treatment area with an antiseptic solution, insert the needle and inject slowly into the deep dermis. Amount, depth and injection method are determined by the physician according to the treatment area. Massage the treatment area after injection for even distribution.

Needle included. Single use only; discard any remaining content. Store at 1–30 °C, protected from light. Do not freeze.

Do not inject into blood vessels, bone, tendons or muscles, or into areas with inflammation or infection. Injection around the eyes is not recommended. Full contraindications and precautions are given in the instructions for use.

Specifications

Item no.:40140
Active ingredient: Cross-linked hyaluronic acid of non-animal origin
Concentration: 24 mg/ml
Format: 2 × 1 ml pre-filled syringes
Injection depth: Deep dermis
Indication: Volume defects, HIV-induced lipoatrophy and facial contour deformities caused by tissue loss
Storage: 1–30 °C, protected from light; shelf life 2 years from manufacture
Classification: CE-marked medical device (CE 2195)

Documentation and compliance

CE-marked medical device

LOT number and Declaration of Conformity accompany every shipment for your patient records.

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Shipping and returns

Ships from our Norwegian warehouse, typically 1 to 2 business days.

Sterile and lot-controlled goods cannot be returned for patient-safety reasons. Contact us for defects or transit damage.

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Frequently asked questions

What is Elasty D?

Elasty D is a sterile, resorbable dermal filler of cross-linked hyaluronic acid (24 mg/ml) from DongBang Medical, for injection into the deep dermis. It is a CE-marked medical device.

What is the product intended for?

According to the manufacturer's instructions for use, the product is intended to replace volume defects, correct HIV-induced lipoatrophy and improve facial contour deformities caused by tissue loss due to accident or disease. Injection in the area around the eyes is not recommended.

How do Elasty D, F and G differ?

They are different models in the Elasty range with the same composition (24 mg/ml) and shared instructions for use. The instructions for use do not specify different areas of use for the models.

How long does the product last?

According to the manufacturer's instructions for use, a preclinical evaluation showed that the product remains implanted in skin tissue for at least 6 months, and it is expected to be fully biodegraded after 1 year.

What adverse effects can occur?

According to the instructions for use, redness, oedema, itching or tenderness may occur in the treatment area and last up to one week. Reactions lasting longer must be reported to the treating physician. A full list of adverse effects and contraindications is given in the instructions for use.

Why BC Nordic

Authorised distributor

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CE marking, Declaration of Conformity and LOT numbers ready for your compliance archive.

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A knowledgeable team that knows the protocols and replies fast.