EDGE BIOLOGICALS INC

Basic Information

• Brand Name: EDGE BIOLOGICALS INC
• Primary DI: B645GS500
• Version / Model: GS500
• Company Name: EDGE BIOLOGICALS, INC.
• Labeler DUNS: 047927827
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-18
• Public Version: 1
• Public Version Date: 2025-04-28
• Public Version Status: New
• Public Device Record Key: f98ee3c9-2387-40b5-8bd4-4b247deb693f
• Distribution End Date: 2025-04-18

Device Description

CRYSTAL VIOLET 30ML

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43733	Gram stain IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in a Gram stain (also referred to as Brown and Benn or Brown-Hopps stain), that is used for the demonstration and differentiation of bacteria in biological/clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B645GS500	HIBCC