Identity
- Trade Name
- INVOcell Culture Device FDA UDI
- Generic Name
- Assisted reproduction procedure dish FDA UDI
- Device Name
- The INVOcell Culture Device is a three-part assembly enclosed in two separate packages. The inner vessel holds culture medium, eggs and sperm, or ICSI fertilized embryos. In an INVOcell procedure, the inner vessel is placed into the outer rigid shell, which provides additional resistance to contamination. Following the loading of gametes or embryos, the INVOcell Culture Device is assembled and placed in the vaginal cavity to allow for embryo development. FDA UDI
- Model / Reference
- FG-002 FDA UDI
- Description
- The INVOcell Culture Device is a three-part assembly enclosed in two separate packages. The inner vessel holds culture medium, eggs and sperm, or ICSI fertilized embryos. In an INVOcell procedure, the inner vessel is placed into the outer rigid shell, which provides additional resistance to contamination. Following the loading of gametes or embryos, the INVOcell Culture Device is assembled and placed in the vaginal cavity to allow for embryo development. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862190000303 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
- 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
INVOcell Culture Device by Invo Bioscience — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction procedure dish.
- VitaVitro — Shenzhen Vitavitro Bio-Tech Co., Ltd. · Class II
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- Metiec — Wuhan Huchuang Union Technology Co., Ltd. · Class II
- SFG Sperm CD — SPECTRUM FERTILITY GROUP INC. · Class II
- Metiec — Wuhan Huchuang Union Technology Co., Ltd. · Class II
- Micro well group culture dish, 9-well — Vitrolife A/S · Class II
- ASTEC IVF 60mm Culture Dish — ASTEC CO., LTD. · Class II
- Nunc IVF ICSI Dish — Nalge Nunc International Corporation · Class II
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 468f7f6f-8771-4f82-82e0-29ca645827b5 35 fields · synced May 30, 2026