Identity
- Trade Name
- INVOcell Retention Device FDA UDI
- Generic Name
- Assisted reproduction procedure dish FDA UDI
- Device Name
- The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone. FDA UDI
- Model / Reference
- P-010 FDA UDI
- Description
- The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862190000310 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
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
INVOcell Retention Device 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 0302eb66-5804-4be9-afab-b8daee6c41a8 36 fields · synced May 31, 2026