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3.0mm Screw Extractor
EUDAMEDFDA UDIClass I (EU MDR)
Ref RS101007
by Tecomet, Inc
Identity
- Trade Name
- 3.0mm Screw Extractor EUDAMEDTecomet FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Screw Extractors EUDAMEDExtractor Assembly, 3.0mm screw FDA UDI
- Model / Reference
- RS101007 EUDAMEDFDA UDI
- Description
- Extractor Assembly, 3.0mm screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069014346 EUDAMEDFDA UDI
- Basic UDI-DI
- 08180690162358MQ EUDAMED
- Direct Marketing DI
- 00818069014346 EUDAMED
- FDA Product Code
- HWB FDA UDI
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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
3.0mm Screw Extractor 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 | 08180690162358MQ | 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 b182f8c2-9ec6-4349-b3d7-3d74c41624f6 61 fields · synced Sep 18, 2026
- FDA UDI 3b015ff1-7303-4e9c-a8ed-20438da91b5e 33 fields · synced May 29, 2026