AccessGUDID - DEVICE: NA (00816576020195)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: J44
Commercial Distribution Status: In Commercial Distribution
Catalog Number: J44
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: CHOC. / M.L. with LINCO. BIPLATE (Chocolate Agar / Martin Lewis with Lincomycin). A biplate for the cultivation and isolation of Neisseria gonorrhoeae.

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):	Yes
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?
58678	Thayer-Martin Neisseria species agar culture medium IVD	A selective and/or differential agar culture medium that uses the Thayer-Martin formulation, or modified formulation, and is intended to be used for the growth and isolation of Neisseria gonorrhoea and other Neisseria species from a clinical specimen.	Obsolete	false
58540	Basic chocolate agar culture medium IVD	A non-selective agar culture medium containing heat-lysed red blood cells intended to be used for the growth and isolation of fastidious bacteria from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JTY	Culture Media, For Isolation Of Pathogenic Neisseria

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 8136c154-938c-4039-b336-5ad5d4ddbc49
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 02, 2016