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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