AccessGUDID - DEVICE: N/A (00816576027262)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: SP57
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP57
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576027262
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Middlebrook 7H11 Thin Pour, for microscopic examination, 10x100mm Space Saver plate, order by the package of 15 For the isolation and detection of mycobacteria using the microcolony method. Thin pour plate for microscopic examination. Use with MycoSeals (cat. no. SS9225)

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?
58688	Enriched agar culture medium IVD	An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZI	Culture Media, Enriched

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
Special Storage Condition, Specify: Store media in the dark

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c827176-63e1-4471-b102-be8e3be85637
Public Version Date: June 15, 2020
Public Version Number: 1
DI Record Publish Date: June 05, 2020