Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Trays EUDAMEDInstrument Tray for Ex Hex / Int. Hex FDA UDI
- Model / Reference
- I-HEX-EG EUDAMEDFDA UDI
- Description
- Instrument Tray for Ex Hex / Int. Hex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544027348 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544039118P EUDAMED
- Direct Marketing DI
- 06009544027348 EUDAMED
- 510(k) Number
- K210923 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical retraction system, reusable
Instrument Trays by Southern Implants (pty) Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210923 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6009544039118P | Class I | Active |
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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 (3)
- EUDAMED 54d37316-72b7-46dd-b3ea-3c27f2d62d87 61 fields · synced Jun 18, 2026
- FDA UDI 7d518644-ad94-426a-b434-0b5c43c8c296 34 fields · synced May 30, 2026
- FDA 510(k) K210923 1 fields · synced May 18, 2026