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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