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1/4 Square Screw Remover, 8mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref RS2013150
by Tecomet, Inc
Identity
- Trade Name
- 1/4 Square Screw Remover, 8mm EUDAMEDTecomet FDA UDI
- Generic Name
- Bone trephine, reusable FDA UDI
- Device Name
- Trephines EUDAMEDRemover Assembly, Broken Screw 8mm 1/4" Male Square Drive FDA UDI
- Model / Reference
- RS2013150 EUDAMEDFDA UDI
- Description
- Remover Assembly, Broken Screw 8mm 1/4" Male Square Drive FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069014469 EUDAMEDFDA UDI
- Basic UDI-DI
- 08180690114147KY EUDAMED
- Direct Marketing DI
- 00818069014469 EUDAMED
- FDA Product Code
- HWB FDA UDI
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
- GMDN Term
- Bone trephine, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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 trephine, reusable
1/4 Square Screw Remover, 8mm by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone trephine, reusable.
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- ZOLL-DENTAL — Zoll-Dental · Class I
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- Borchardt Flat Trephine 5 mm Borchardt Shaft Ø 1.8 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
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 | 08180690114147KY | 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 51f8d6f0-0e68-4d0c-a839-4860d6e8851f 61 fields · synced Sep 18, 2026
- FDA UDI 83f7621b-e2eb-4e28-906e-2b942539974e 33 fields · synced May 30, 2026