Identity
- Trade Name
- Gingiva punch EUDAMEDGuide Gingiva punch FDA UDI
- Generic Name
- Dental soft-tissue coring punch, single-use FDA UDI
- Device Name
- Guide Gingiva punch EUDAMEDGuide Gingiva punch Ø 4.3 mm FDA UDI
- Model / Reference
- J5041.4303 EUDAMEDFDA UDI
- Description
- Guide Gingiva punch Ø 4.3 mm FDA UDI
Identifiers
- Catalog Number
- J5041.4303 FDA UDI
- Primary DI / UDI-DI
- 04099797994650 EUDAMEDE219J504143031 FDA UDI
- Basic UDI-DI
- 40997970004025000000000HL EUDAMED
- Secondary DI
- E219J504143031 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental soft-tissue coring punch, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gingiva punch by ALTATEC GmbH — 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 | 40997970004025000000000HL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 8d3f3508-ea06-497f-8e68-5f229cf880a4 61 fields · synced Jul 24, 2026
- FDA UDI 6ca8b87f-fb53-4cc8-aaff-eb09500dce4a 35 fields · synced May 30, 2026