Identity
- Trade Name
- INVOcell Holding Block FDA UDI
- Generic Name
- Assisted reproduction procedure dish FDA UDI
- Device Name
- The INVOcell Holding Block is used with the INVOcell Culture Device to aid in temperature maintenance of the INVOcell Culture Device during loading and collection procedures and to aid in positioning and observation of the INVOcell Culture Device during human gamete/embryo loading and collection procedures. The INVOcell Holding Block is stainless steel with a glass-viewing window. FDA UDI
- Model / Reference
- P-007 FDA UDI
- Description
- The INVOcell Holding Block is used with the INVOcell Culture Device to aid in temperature maintenance of the INVOcell Culture Device during loading and collection procedures and to aid in positioning and observation of the INVOcell Culture Device during human gamete/embryo loading and collection procedures. The INVOcell Holding Block is stainless steel with a glass-viewing window. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862190000327 FDA UDI
- 510(k) Number
- DEN150008 FDA UDI
- FDA Product Code
- OYO FDA UDI
- GMDN Term
- Assisted reproduction procedure dish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6165 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Liquid Chemical FDA UDI
INVOcell Holding Block by Invo Bioscience — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
DEN150008 also covers:
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
- Invo Bioscience
Sources (1)
- FDA UDI 8ff15c4f-c7b6-4164-8379-636f722d89c6 36 fields · synced May 30, 2026