Identity
- Trade Name
- Geri Dish FDA UDI
- Generic Name
- Assisted reproduction procedure dish FDA UDI
- Device Name
- The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator. FDA UDI
- Model / Reference
- GERI-DSH-20 FDA UDI
- Description
- The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348265003017 FDA UDI
- 510(k) Number
- K171736 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- Assisted reproduction procedure dish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction procedure dish
Geri Dish by Genea Biomedx Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Genea Biomedx Pty Ltd
Sources (1)
- FDA UDI 3930cb5b-742b-4afa-8ab8-bdc7d23f9290 34 fields · synced Jun 6, 2026