Identity
- Trade Name
- Newclip Instruments FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- Instrumentation class I with measuring function EUDAMED
- Model / Reference
- ANC014-2 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- ANC014-2 FDA UDI
- Primary DI / UDI-DI
- 03700569619169 EUDAMEDFDA UDI
- Basic UDI-DI
- 37005696006092 EUDAMED
- FDA Product Code
- HTZ FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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: Osteotomy guide, reusable
Newclip Instruments by Newclip Technics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 2fba45ba-0a3a-4dd9-b65a-0d7f9c741be7 33 fields · synced Jun 18, 2026
- EUDAMED b54656e1-cf01-4e87-8c2c-9a744b9c4e3e 61 fields · synced Jun 18, 2026