AccessGUDID - DEVICE: LabChoice Cryogenic Tubes, With Graduated Markings, 2mL,Sterile (00840117337312)

GUDID

Device Identifier (DI) Information

Brand Name: LabChoice Cryogenic Tubes, With Graduated Markings, 2mL,Sterile
Version or Model: 42400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117337312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: STERILE-R

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":	Yes
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?
57834	Assisted reproduction cryotube	A sterile container (a dedicated sealable tube) intended for transport, storage and preparation of biological samples of human origin used in assisted reproduction techniques (ART), e.g., embryos. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF) and ART clinics. Its main application being to hold biological materials when stored in a frozen state at temperatures below -130 Celsius (e.g., stored in the gas phase above the liquid nitrogen (LN2) at temperatures around -178 C to -150 C). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	Container, Specimen, Sterile

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a92b707b-58a9-45e7-b3d0-5e7347468368
Public Version Date: March 13, 2025
Public Version Number: 1
DI Record Publish Date: March 05, 2025