EDGE BIOLOGICALS INC

Basic Information

• Brand Name: EDGE BIOLOGICALS INC
• Primary DI: B645T0486
• Version / Model: T0486
• Company Name: EDGE BIOLOGICALS, INC.
• Labeler DUNS: 047927827
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-04-21
• Public Version: 1
• Public Version Date: 2025-04-29
• Public Version Status: New
• Public Device Record Key: 82ded179-4bc8-427f-8af2-f8c1cc6f7260
• Distribution End Date: 2025-04-21

Device Description

NUTRIENT GELATIN 5ML

Device Characteristics

• Single Use: Yes
• 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
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	866.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62082	Nutrient gelatin culture medium IVD	A non-selective culture medium containing gelatin intended to be used to detect gelatin liquefaction by a gelatinase-producing microorganism and for the general growth and isolation of microorganisms from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B645T04861	HIBCC
Primary	B645T0486	HIBCC