AccessGUDID - DEVICE: N/A (00819398024587)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Y10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Y10
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398024587
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2023
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: CTA (Cystine Tryptic Agar) with Cellobiose, 3ml fill, deep, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the determination of carbohydrate fermentation by fastidious organisms, such as Neisseria spp. It is also used for the detection of bacterial motility and serves as a culture media for microorganism maintenance.

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
JSF	Culture Media, Single Biochemical Test

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: 900b7ef9-ab17-4e97-8d28-e1ddf096ef8a
Public Version Date: May 03, 2023
Public Version Number: 2
DI Record Publish Date: June 08, 2020