Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
- Device Name
- Laboratory Components EUDAMEDHexed Brass Screw for Int. Hex Passive Abutment FDA UDI
- Model / Reference
- PA-M-18B EUDAMEDFDA UDI
- Description
- Hexed Brass Screw for Int. Hex Passive Abutment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544018148 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544038799L EUDAMED
- Direct Marketing DI
- 06009544018148 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Laboratory Components 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 | 6009544038799L | 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 (2)
- EUDAMED 7e8583b2-03a7-4c1e-ac19-160b273c2898 61 fields · synced Jul 31, 2026
- FDA UDI 95ddb647-9761-4215-a866-2911d6f4db89 33 fields · synced May 30, 2026