Collagen Membrane Barrier for Orthopedic & Dental Surgeries

0 out of 5

Description

GENERAL FEATURES

TypeResorbable collagen membrane (RCM)
ApplicationGuided Tissue Regneration or Guided Bone Regeneration
UsageOral surgeons, Periodontists, Orthodontists, Endodontists and Orthopaedics
UtilityOrthopeadic surgeries & Dental surgeries

PRODUCT INFORMATION

Thin sheetYes
Number of Sheets of membraneSingle
Porus structure with smooth surface on other sideYes
Tissue side and Bone side indicatedYes
Bio-resorbableYes
Highly bio-compatibleYes
Highly purifiedYes
High mechanical strengthYes
Soft and drapableYes
Does not stick to instrumentsYes
Implantable for guided tissue regeneration of bone damagesYes
Easy to reposition for precise adjustment and placement as neededYes
SterileYes
Method of sterilizationGamma

DIMENSIONS & MATERIAL

Size (LxW) (mmxmm)10×10
Material of collagen membraneManufactured from purified porcine/Bovine tissue

STANDARD

Product conformity to standardEU-CE&US-FDA

PACKING & MARKING

Packing typeSterile
Packing modeSealed pack
Sealed pack printed with the details of Manufacturer name, description of drug, Lot No etcYes

CERTIFICATIONS & REPORTS

Submission of Test Report on form 39 or from Central Govt/NABL/ILAC accredited Lab to prove the conformity to declared specification at the time of supplyYes
Should Confirm that the packing is original as manufactured by the OEM ie not repacked or refurbished by the supplierYes
Should produce copies of all documents for import, manufacture and sale as per Central Drugs Standard Control Organisation of India at the time of supplyYes
Tissue implantation testing certificate to be providedYes
Certifications AvailableEU-CE & US-FDA
Product conformity certificate is to be provided to the buyer at the time of supplyYes
Availability of valid manufacturing Drug LicenseYes
Drug License NoCE 0134857
Drug License DateDT 20/01/2003

SHELF LIFE

Minimum shelf life at the time of supply (Yrs)2
Replacement of sealed pack against manufacturing defects within shelf lifeYes

Reviews

There are no reviews yet.

Be the first to review “Collagen Membrane Barrier for Orthopedic & Dental Surgeries”