← Back to catalogue
Pin Cutter End Bite
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2167-12-000
by Tecomet, Inc
Identity
- Trade Name
- PIN CUTTER END BITE EUDAMEDTecomet FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- DBL ACTION WIRE CUTTER EUDAMEDPIN CUTTER END BITE FDA UDI
- Model / Reference
- 2167-12-000 EUDAMEDFDA UDI
- Description
- PIN CUTTER END BITE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841435120105 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841435144805UK EUDAMED
- Direct Marketing DI
- 00841435120105 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 End Bite by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone cutting forceps, reusable.
- Acetabular Reamer 47mm — Viant Medical, LLC · Class IIa
- Gimmi — Gimmi GmbH · Class I
- GLOBAL UNITE — DePuy Ireland UC · Class I
- KNEO FEMORAL CUTTING BLOCK S08 — groupe lépine · Class I
- AG15-0002 — X.NOV MEDICAL TECHNOLOGY · Class I
- SPECIALIST 2 — DePuy Ireland UC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Acetabular Reamer 55mm — Viant Medical, LLC · Class IIa
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 | 0841435144805UK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecomet, Inc
- EUDAMED SRN
- US-MF-000027544
- Authorised Representative
- Meditec Source GmbH & Co. KG DE-AR-000009318
Sources (2)
- EUDAMED 063386e1-e830-4bab-820f-5c65866572f5 61 fields · synced Sep 18, 2026
- FDA UDI 1b3153b5-70e8-4486-a0bd-87da1717085a 33 fields · synced May 30, 2026