Identity
- Trade Name
- Newclip Instruments FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Instrumentation class IIa EUDAMED
- Model / Reference
- ANC188 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- ANC188 FDA UDI
- Primary DI / UDI-DI
- 03700569620226 EUDAMEDFDA UDI
- Basic UDI-DI
- 37005696004698 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fluted surgical drill bit, reusable
Newclip Instruments by Newclip Technics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Fluted surgical drill bit, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Newclip Technics
Sources (2)
- FDA UDI 528cb4ff-7f1e-4755-9543-ed4f5f72c49d 33 fields · synced Jul 31, 2026
- EUDAMED 74230891-aca5-477c-bf40-a8d5f2093557 61 fields · synced Jul 31, 2026