Identity
- Trade Name
- Guided Tissue Punch for RP-sleeve EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Dental soft-tissue coring punch, reusable FDA UDI
- Device Name
- Tissue punches - Guided EUDAMEDGuided Tissue Punch for RP-sleeve FDA UDI
- Model / Reference
- 37154 EUDAMEDFDA UDI
- Description
- Guided Tissue Punch for RP-sleeve FDA UDI
Identifiers
- Catalog Number
- 37154 FDA UDI
- Primary DI / UDI-DI
- 07332747211504 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001877M EUDAMED
- Direct Marketing DI
- 07332747070323 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental soft-tissue coring punch, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Guided Tissue Punch for RP-sleeve by Nobel Biocare AB — Class IIa — 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 | 73327470000001877M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 90b33512-5124-46e5-8c03-73e5ea6189c0 61 fields · synced Jul 11, 2026
- FDA UDI 23de78a6-9926-41b1-a050-7a269df141d1 36 fields · synced May 30, 2026