AccessGUDID - DEVICE: EDGE BIOLOGICALS INC (B645GS901)

GUDID

Device Identifier (DI) Information

Brand Name: EDGE BIOLOGICALS INC
Version or Model: GS901
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EDGE BIOLOGICALS, INC.

Primary DI Number: B645GS901
Issuing Agency: HIBCC
Commercial Distribution End Date: April 18, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 047927827 *Terms of Use

Device Description: METHYLENE BLUE STAIN 100ML

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:	No
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?
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: 151f0d58-cdd0-43ca-b9c6-1639c7c287a3
Public Version Date: April 28, 2025
Public Version Number: 1
DI Record Publish Date: April 18, 2025