Identity
- Trade Name
- GEM MICROTRAY FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- A highly perforated, reusable, single tier, sterilization tray consisting of an anodized aluminum base and cover with handles and latches and a full finger mat and instrument holder bar. FDA UDI
- Model / Reference
- GEM2551C FDA UDI
- Description
- A highly perforated, reusable, single tier, sterilization tray consisting of an anodized aluminum base and cover with handles and latches and a full finger mat and instrument holder bar. FDA UDI
Identifiers
- Catalog Number
- 519400002011 FDA UDI
- Primary DI / UDI-DI
- 00844735003758 FDA UDI
- 510(k) Number
- K071783 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Gem Microtray by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071783 also covers:
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY MAX — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM MICROTRAY MAX — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM Microvascular Anastomotic COUPLER Sterilization Tray — SYNOVIS MICRO COMPANIES ALLIANCE, INC
- GEM Microvascular Anastomotic COUPLER System — SYNOVIS MICRO COMPANIES ALLIANCE, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synovis Micro Companies Alliance, Inc
Sources (1)
- FDA UDI cd7cf981-5cb4-47a1-b35f-a255998436ea 36 fields · synced Jun 1, 2026