Identity
- Trade Name
- R.T.R Membrane FDA UDI
- Generic Name
- Dental/maxillofacial soft-tissue biomatrix implant, animal-derived FDA UDI
- Device Name
- Absorbable Collagen Membrane (30X40MM) for dental surgery. FDA UDI
- Model / Reference
- 9627O FDA UDI
- Description
- Absorbable Collagen Membrane (30X40MM) for dental surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760140703625 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Dental/maxillofacial soft-tissue biomatrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
R.T.R Membrane by Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial soft-tissue biomatrix implant, animal-derived.
- SALVIN ORAMEM — SALVIN DENTAL SPECIALTIES, LLC · Class II
- Integra® Miltex® Helimend® Advanced — Integra Lifesciences Corp. · Class II
- ORAMEM-SUS-15X20 — SALVIN DENTAL SPECIALTIES, LLC · Class II
- ORAMEM-SUS-30X40 — SALVIN DENTAL SPECIALTIES, LLC · Class II
- Geistlich Mucograft® Seal — Geistlich Pharma AG · Class II
- Geistlich Fibro-Gide® — Geistlich Pharma AG · Class II
- Geistlich Mucograft® Seal — Geistlich Pharma AG · Class II
- Integra® Miltex® Helimend® Advanced — Integra Lifesciences Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Septodont
Sources (1)
- FDA UDI 447393d8-7771-4b53-bdd2-22674f16aa22 33 fields · synced May 30, 2026