Beltade info
Beltade HA fillers are based on a unique BDDE crosslinking technology
Product Description
Beltade Filler
The medical device is a sterile, injectable, pyrogen-free, monophasic hydrogel composed sodium hyaluronate cross-linked by BDDE, with glycine and Lproline in buffered non pyrogenic water.
The sodium hyaluronate is a highly purified raw material, obtained by
bacterial fermentation (biotechnological method).
The hydrogel production happens through cross-linking of sodium hyaluronate chains by means of 1,4-butanediol diglycidyl ether (BDDE).
This product is a biocompatible medical device for medical-surgical use, indicated for the temporary correction of acquired and congenital soft tissue deficits.
After surgical implantation, the product is subjected to a slow degradation process.
The product is a monophasic hydrogel that remains cohesive in presence of water, while biphasic products are more dispersive and will separate to form visible micro-particles. This monophasic hydrogel has mechanical characteristics of viscous-elasticity with good resistance at compression.
The gel withstands to steam sterilization, climatic influences during transport and mechanical stress once packaged. This medical device is sold in disposable syringes, packed individually in rigid blister. The device is supplied in STERILE condition.
The Hyaluronic acid hydrogel crosslinked by BDDE soft tissue filler has been designed in different concentration of sodium hyaluronate: 18 mg/ml, 24mg/ml and 28mg/ml.
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INTENDED USE
The Hyaluronic acid hydrogel crosslinked by BDDE is a medical device for medical-surgical use, for temporary correction of acquired and congenital soft tissues deficits via injections.
The product is suitable for injection into the intradermal and hypodermis Thanks to its plastic properties, this product is capable to correcting areas of different consistency.
TECHNICAL SPECIFICATIONS OF THE PRODUCT
The Hyaluronic acid hydrogel crosslinked by BDDE is a medical device for medical-surgical use, for temporary correction of acquired and congenital soft tissues deficits via injections.
The product is suitable for injection into the intradermal and hypodermis Thanks to its plastic properties, this product is capable to correcting areas of different consistency.
– The hyaluronic acid hydrogel cross-linked by BDDE has a threedimensional structure obtained with a cross-linking process of sodium hyaluronate chains. – The final product is gelatinous, transparent and colourless. – It’s STERILE. – The hydrogel has the following chemical/physical characteristics:
| Following Chemical | Physical characteristics |
|---|---|
|
Visual appearance: |
Gelatinous, transparent |
|
Dry residue: |
3.5 + 1.5 % |
|
pH: |
6.5 + 1.0 |
|
BDDE residue: |
<2ppm |
|
Sterility: |
Sterile |
|
Endotoxin: |
<0.5 EU/ml |
PRODUCT’S USEFUL LIFE
The shelf life of the product is three years, the product must be used before the expiry date indicated on the labelling (syringe and paper case).
STORAGE AND TRANSPORT CONDITIONS
The product must be stored at a temperature between +4°C and +27°C.
Protect the product from direct sunlight and/or from freezing.
The product is not subjected to specific condition of temperature during the transport and the product preserves its stability also during long transport
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