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General Use Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref I-M2Ref I-GSF-5142-L4Ref I-IMP-REMRef I-GSF-5142-L6
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Dental implant extractor FDA UDIDental implant internal thread shaping tool FDA UDI
- Device Name
- General Use Instruments EUDAMEDInstrument, Implant Remover, Wrench Insert FDA UDIInstrument, Screw Tap, M2 FDA UDI
- Model / Reference
- I-M2 EUDAMEDFDA UDII-GSF-5142-L4 EUDAMEDI-IMP-REM EUDAMEDFDA UDII-GSF-5142-L6 EUDAMED
- Description
- Instrument, Implant Remover, Wrench Insert FDA UDIInstrument, Screw Tap, M2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544012405 EUDAMEDFDA UDI06009544050957 EUDAMED06009544012085 EUDAMEDFDA UDI06009544050964 EUDAMED
- Basic UDI-DI
- 6009544039108M EUDAMED
- Direct Marketing DI
- 06009544012405 EUDAMED06009544050957 EUDAMED06009544012085 EUDAMED06009544050964 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant extractor FDA UDIDental implant internal thread shaping tool FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
General Use Instruments by Southern Implants (pty) Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 6009544039108M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Southern Implants (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000035362
- Authorised Representative
- Southern Implants Europe AB SE-AR-000032508
Sources (7)
- EUDAMED 441593d7-3f75-407a-bacd-38a843f5c4cb 61 fields · synced Aug 2, 2026
- EUDAMED fcc64693-6b2d-45ad-92e7-863262137fbb 61 fields · synced May 16, 2026
- EUDAMED 5281b6c1-522d-4afb-b0cc-1a63f0fb76eb 61 fields · synced May 17, 2026
- EUDAMED 9968f4e8-9c56-4197-9764-3860ede16af7 61 fields · synced May 18, 2026
- FDA UDI b31b7210-0385-41cb-8a9a-b5f7c474e57a 33 fields · synced May 30, 2026
- FDA UDI 27bee4f2-b612-45f9-9dec-a7e78399183d 33 fields · synced May 30, 2026
- EUDAMED 0ec2c46d-942e-497a-b066-23cf38b1844b 61 fields · synced Jul 12, 2026