AccessGUDID - DEVICE: EDGE BIOLOGICALS INC (B6452B019)

GUDID

Device Identifier (DI) Information

Brand Name: EDGE BIOLOGICALS INC
Version or Model: 2B019
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EDGE BIOLOGICALS, INC.

Primary DI Number: B6452B019
Issuing Agency: HIBCC
Commercial Distribution End Date: April 16, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 047927827 *Terms of Use

Device Description: Blood Agar/EMB BiPlate

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?
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSH	Culture Media, Non-Selective And 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 38432acc-efbb-44c4-88a2-23a34c0ffc77
Public Version Date: April 24, 2025
Public Version Number: 1
DI Record Publish Date: April 16, 2025