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Pin Cutter Side Bite
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2167-10-000
by Tecomet, Inc
Identity
- Trade Name
- Tecomet FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- PIN CUTTER SIDE BITE EUDAMEDFDA UDI
- Model / Reference
- 2167-10-000 EUDAMEDFDA UDI
- Description
- PIN CUTTER SIDE BITE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069014902 EUDAMEDFDA UDI
- Basic UDI-DI
- 08180690144805ML EUDAMED
- Direct Marketing DI
- 00818069014902 EUDAMED
- FDA Product Code
- FZT FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implantable-device cutter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutting forceps, reusable
Pin Cutter Side Bite by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 08180690144805ML | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tecomet, Inc
- EUDAMED SRN
- US-MF-000027544
- Authorised Representative
- Meditec Source GmbH & Co. KG DE-AR-000009318
Sources (2)
- EUDAMED 6fbe8c6d-9515-4ca3-bee3-35da8c1dba8d 61 fields · synced Sep 18, 2026
- FDA UDI 4a665f46-fb8a-4793-93ad-5916c8d2d211 33 fields · synced May 30, 2026