Handheld Rod Cutter, Side Cut 4mm 14.5"
EUDAMEDFDA UDIClass I (EU MDR)
by Tecomet, Inc
Identity
- Trade Name
- Handheld Rod Cutter, Side Cut 4mm 14.5" EUDAMEDTecomet FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- PIN CUTTER SIDE BITE EUDAMEDHand Held Rod Cutter, Side Cutting FDA UDI
- Model / Reference
- KM46629 EUDAMEDFDA UDI
- Description
- Hand Held Rod Cutter, Side Cutting FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069015183 EUDAMEDFDA UDI
- Basic UDI-DI
- 08180690144805ML EUDAMED
- Direct Marketing DI
- 00818069015183 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Bone cutting forceps, reusable
Handheld Rod Cutter, Side Cut 4mm 14.5" 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
CE/MDR
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 db81d406-eb81-4eb6-b1ba-f0f503ab93f0 61 fields · synced Sep 18, 2026
- FDA UDI 5187bf1c-10d0-42f6-8524-b705c577ddd7 33 fields · synced May 30, 2026