AccessGUDID - DEVICE: INVOcell Retention Device (00862190000310)

GUDID

Device Identifier (DI) Information

Brand Name: INVOcell Retention Device
Version or Model: P-010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INVO BIOSCIENCE, INC.

Primary DI Number: 00862190000310
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 829694889 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56648	Assisted reproduction procedure dish	A container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYO	Culture, Intravaginal, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN150008	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store away from moisture and direct heat
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0302eb66-5804-4be9-afab-b8daee6c41a8
Public Version Date: February 20, 2023
Public Version Number: 6
DI Record Publish Date: September 23, 2016