AccessGUDID - DEVICE: N/A (00816576026012)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: G62
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: G62
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576026012
Issuing Agency: GS1
Commercial Distribution End Date: April 21, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Tryptic Soy Agar (TSA) (without plate label, orientation tabs, and logo), 15x100ml Plate, 23ml. Hardy Diagnostics Tryptic Soy Agar is recommended for use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance and transportation of pure cultures of microorganisms.

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?
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	Culture Media, Non-Selective And Non-Differential

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0852c373-b6cd-4120-a15c-c5e0c038a292
Public Version Date: April 22, 2022
Public Version Number: 2
DI Record Publish Date: May 20, 2020