Identity
- Trade Name
- MEDENTiKA FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Placing Instrument angle Ball Torx FDA UDI
- Model / Reference
- M 03-8 FDA UDI
- Description
- Placing Instrument angle Ball Torx FDA UDI
Identifiers
- Catalog Number
- M 03-8 FDA UDI
- Primary DI / UDI-DI
- EMKAM0389 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Surgical screwdriver, reusable
MEDENTiKA by Medentika GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
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 |
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Manufacturer
- Manufacturer
- Medentika GmbH
Sources (1)
- FDA UDI 3a0f6941-0176-4280-9e92-84077045df02 35 fields · synced May 30, 2026