AccessGUDID - DEVICE: INVOcell Culture Device (00862190000303)

GUDID

Device Identifier (DI) Information

Brand Name: INVOcell Culture Device
Version or Model: FG-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INVO BIOSCIENCE, INC.

Primary DI Number: 00862190000303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829694889 *Terms of Use

Device 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.

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: Yes
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: 468f7f6f-8771-4f82-82e0-29ca645827b5
Public Version Date: February 20, 2023
Public Version Number: 5
DI Record Publish Date: September 23, 2016