AccessGUDID - DEVICE: NA (00816576020126)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: G47
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G47
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: MRSA SCREEN PLATE (Mueller Hinton with 4% NaCl and Oxacillin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus.

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?
58638	MRSA agar culture medium IVD, selective antimicrobial	A selective and/or differential agar culture medium containing a defined concentration of selective antimicrobials (e.g. methicillin, oxacillin, cephalosporin) intended to be used to screen for the presence of methicillin-resistant Staphylococcus aureus (MRSA) microorganisms in a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

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: b4fb736d-d198-4daa-b305-b3d3e627de73
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 02, 2016