AccessGUDID - DEVICE: STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15 (03661532000486)

GUDID

Device Identifier (DI) Information

Brand Name: STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 017798
Company Name: CRYO BIO SYSTEM

Primary DI Number: 03661532000486
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:	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?
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
MQG	Accessory, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002595	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6f0df78-6508-41e4-a6a1-754920f66fb4
Public Version Date: November 11, 2020
Public Version Number: 1
DI Record Publish Date: November 03, 2020