Identity
- Trade Name
- Composi-Tight® Matrix Forceps EUDAMEDComposi-Tight® FDA UDI
- Generic Name
- Rubber dam clamp forceps FDA UDI
- Device Name
- Instruments Family EUDAMEDMatrix Forceps, Angled Tip FDA UDI
- Model / Reference
- BFA-1 EUDAMEDFDA UDI
- Description
- Matrix Forceps, Angled Tip FDA UDI
Identifiers
- Catalog Number
- BFA-1 FDA UDI
- Primary DI / UDI-DI
- 00810038093772 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809InstrumentsTFTF EUDAMED
- FDA Product Code
- EJG FDA UDI
- EMDN Code
- L15901101 POSITIONING INSTRUMENTS FOR DENTAL MATRICES, REUSABLE EUDAMED
- GMDN Term
- Rubber dam clamp forceps FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Composi-Tight® Matrix Forceps by Garrison Dental Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003809InstrumentsTFTF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (2)
- EUDAMED c37b0991-eafd-4383-b5b9-c21208f2f217 61 fields · synced Jul 15, 2026
- FDA UDI 790f2889-52af-4138-88cc-8cd7173f6988 35 fields · synced May 30, 2026