Collagen Membrane Barrier for Orthopedic & Dental Surgeries

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Description

GENERAL FEATURES

Type Resorbable collagen membrane (RCM)
Application Guided Tissue Regneration or Guided Bone Regeneration
Usage Oral surgeons, Periodontists, Orthodontists, Endodontists and Orthopaedics
Utility Orthopeadic surgeries & Dental surgeries

PRODUCT INFORMATION

Thin sheet Yes
Number of Sheets of membrane Single
Porus structure with smooth surface on other side Yes
Tissue side and Bone side indicated Yes
Bio-resorbable Yes
Highly bio-compatible Yes
Highly purified Yes
High mechanical strength Yes
Soft and drapable Yes
Does not stick to instruments Yes
Implantable for guided tissue regeneration of bone damages Yes
Easy to reposition for precise adjustment and placement as needed Yes
Sterile Yes
Method of sterilization Gamma

DIMENSIONS & MATERIAL

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

STANDARD

Product conformity to standard EU-CE&US-FDA

PACKING & MARKING

Packing type Sterile
Packing mode Sealed pack
Sealed pack printed with the details of Manufacturer name, description of drug, Lot No etc Yes

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 supply Yes
Should Confirm that the packing is original as manufactured by the OEM ie not repacked or refurbished by the supplier Yes
Should produce copies of all documents for import, manufacture and sale as per Central Drugs Standard Control Organisation of India at the time of supply Yes
Tissue implantation testing certificate to be provided Yes
Certifications Available EU-CE & US-FDA
Product conformity certificate is to be provided to the buyer at the time of supply Yes
Availability of valid manufacturing Drug License Yes
Drug License No CE 0134857
Drug License Date DT 20/01/2003

SHELF LIFE

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

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