AccessGUDID - DEVICE: Globe Scientific (00840095686549)

GUDID

Device Identifier (DI) Information

Brand Name: Globe Scientific
Version or Model: 3034-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GLOBE SCIENTIFIC INC.

Primary DI Number: 00840095686549
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 106793995 *Terms of Use

Device Description: Cryogenic Vials, 2.0ml, Sterile, Internal Threads, Attached Screwcap with O-ring seal, RB, SS, PG, WS

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?
64783	Microbial cryotube IVD	A vial containing porous glass or synthetic polymer beads and/or a liquid cryoprotectant intended to be used for the cryopreservation, storage, and subsequent retrieval of clinical microbial isolates (e.g., bacteria, fungi) for in vitro diagnostic applications. The container enables preservation and storage of the microbial specimens at sub-zero temperatures for extended periods. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDT	Container, Specimen Mailer And Storage, 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: 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: 73e145a4-de75-4a95-9427-57c44583e183
Public Version Date: August 17, 2023
Public Version Number: 1
DI Record Publish Date: August 09, 2023