AccessGUDID - DEVICE: PRAS Reinforced Clostridial Agar (RCA) (00810048900312)

GUDID

Device Identifier (DI) Information

Brand Name: PRAS Reinforced Clostridial Agar (RCA)
Version or Model: AS-6061
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-6061
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048900312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-6061 Reinforced Clostridial Agar (RCA) is an enriched non-selective medium intended for the cultivation of Clostridia and other anaerobic and facultative bacteria from various clinical and non-clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow. 4 plates per pack.

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?
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used 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
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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd253553-ab6d-4f2c-b7fa-5015c2882813
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020