AccessGUDID - DEVICE: Microbank Dry - Yellow (80 vials) (10628429000912)

GUDID

Device Identifier (DI) Information

Brand Name: Microbank Dry - Yellow (80 vials)
Version or Model: PL.172/Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL.172/Y
Company Name: PRO-LAB, INCORPORATED

Primary DI Number: 10628429000912
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 960418395 *Terms of Use

Device Description: Supplied in the same format as traditional Microbank™ without the specially formulated cryopreservation solution.

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?
58586	Basic/simple nutrient broth culture medium IVD	A non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSC	Culture Media, General Nutrient Broth

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: 4497dbb4-024b-4e34-bf4a-e8830489a82e
Public Version Date: December 29, 2022
Public Version Number: 1
DI Record Publish Date: December 21, 2022