Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Dental implant holding endpiece, reusable FDA UDI
- Device Name
- Reusable Instruments EUDAMEDPeek Bit for Tri-Nex Insertion Tool, M2 FDA UDI
- Model / Reference
- I-PBIT-L2 EUDAMEDFDA UDI
- Description
- Peek Bit for Tri-Nex Insertion Tool, M2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544012849 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544038769E EUDAMED
- Direct Marketing DI
- 06009544012849 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant holding endpiece, 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Surgical retraction system, reusable
The Reusable Instruments are a line of medical devices designed for safe and effective use in various healthcare settings. These instruments are made with high-quality materials, ensuring durability and precision. With their simple design, they can be easily integrated into existing equipment, making them an excellent addition to any medical device portfolio.
Similar devices
Also classified as Surgical retraction system, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6009544038769E | 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 a35567d0-62e1-4d46-86c4-8f9754c80920 61 fields · synced Jul 18, 2026
- FDA UDI 18f361d2-288c-4a67-a5d4-bac21507ea93 33 fields · synced May 30, 2026