Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Trays EUDAMEDInstrument Tray for Zygomatic, Large FDA UDIInstrument Tray, ZAGA™ Zygomatic Implant System FDA UDI
- Model / Reference
- CH-I-ZYG EUDAMEDFDA UDII-ZYG-EG EUDAMEDFDA UDI
- Description
- Instrument Tray for Zygomatic, Large FDA UDIInstrument Tray, ZAGA™ Zygomatic Implant System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009544036708 EUDAMEDFDA UDI06009544050643 EUDAMEDFDA UDI
- Basic UDI-DI
- 6009544039118P EUDAMED
- Direct Marketing DI
- 06009544036708 EUDAMED06009544050643 EUDAMED
- 510(k) Number
- K210923 FDA UDI
- FDA Product Code
- KCT FDA UDINDP FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMEDV0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMEDGermany 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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Instrument Trays 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 | 6009544039118P | 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 (5)
- EUDAMED 55ec2128-967f-46b0-883e-ca55b527c19a 61 fields · synced Jul 14, 2026
- EUDAMED 4d541a1d-a073-4d58-ba1f-c559f6619fc3 61 fields · synced May 18, 2026
- FDA UDI 16841b5d-3170-41ed-be55-950c60c2e941 34 fields · synced May 30, 2026
- FDA UDI 61bd0013-f73f-48fe-af48-8f14281b2e8a 33 fields · synced May 30, 2026
- EUDAMED 79f6b8d7-de60-4201-91bf-f23bc967e9be 61 fields · synced Jul 10, 2026