AccessGUDID - DEVICE: BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS

GUDID

Device Identifier (DI) Information

Brand Name: BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - PINK
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 025249
Company Name: CRYO BIO SYSTEM

Primary DI Number: 03661532002992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 500731872 *Terms of Use

Device Description: No description.

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):	No
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?
48008	Tissue cryostorage straw vitrification set	A collection of sterile devices designed for use in the vitrification process and cryopreservation of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It typically consists of a tissue storage straw, a curved spatula or capillary tube (used for the capture of the specimen) which may be colour-coded, and an insertion device for positioning of the spatula or capillary tube with the specimen into the tissue collection straw. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c5cc7b9-4f42-4503-a328-0b6db2a6e3e2
Public Version Date: November 09, 2020
Public Version Number: 1
DI Record Publish Date: October 30, 2020