AccessGUDID - DEVICE: cryo-GO Vitrification Device - Green (Pack of 50) (00810195240088)

GUDID

Device Identifier (DI) Information

Brand Name: cryo-GO Vitrification Device - Green (Pack of 50)
Version or Model: 70315-G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70315-G
Company Name: IRVINE SCIENTIFIC, LLC

Primary DI Number: 00810195240088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121584789 *Terms of Use

Device Description: cryo-GO Vitrification Device - Green (Pack of 50). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryos cryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.

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:	Yes
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?
47446	Assisted reproduction vitrification carrier	A sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQK	Labware, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2970bd01-a22f-4ff7-83c2-38012ade1933
Public Version Date: June 10, 2025
Public Version Number: 1
DI Record Publish Date: June 02, 2025