INVOcell Retention Device

FDA UDI

Class II (US FDA UDI)

by Invo Bioscience

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, medical grade silicone device 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 the incubation period. FDA UDI
Model / Reference: P-011 FDA UDI
Description: The INVOcell Retention Device is a single-use, medical grade silicone device 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 the incubation period. FDA UDI

Identifiers

Primary DI / UDI-DI: 00862190000358 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Assisted reproduction procedure dish

INVOcell Retention Device by Invo Bioscience — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Assisted reproduction procedure dish.

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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 b773a733-25ed-456c-bec4-c84b2e273767 35 fields · synced May 29, 2026