Identity
- Trade Name
- GEM MICROTRAY FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- A highly perforated, reusable, double tier, sterilization tray consisting of an anodized aluminum base, insert, and cover with handles and latches and full finger mats on both upper and lower tiers. FDA UDI
- Model / Reference
- GEM2551-2 FDA UDI
- Description
- A highly perforated, reusable, double tier, sterilization tray consisting of an anodized aluminum base, insert, and cover with handles and latches and full finger mats on both upper and lower tiers. FDA UDI
Identifiers
- Catalog Number
- 519400003011 FDA UDI
- Primary DI / UDI-DI
- 00844735003765 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 15a018cd-11ee-4668-8ed9-714bb873b8ee 36 fields · synced May 30, 2026