Identity
- Trade Name
- MEDENTiKA FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Drilling sleeve FDA UDI
- Model / Reference
- E 42 RK FDA UDI
- Description
- Drilling sleeve FDA UDI
Identifiers
- Catalog Number
- E 42 RK FDA UDI
- Primary DI / UDI-DI
- EMKAE42RK9 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
MR Conditional FDA UDI
Category: Surgical drill guide, single-use
MEDENTiKA by Medentika GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medentika GmbH
Sources (1)
- FDA UDI 1bcc4544-8438-44da-9f22-ae036f698b0c 36 fields · synced Jun 1, 2026