REMEL

Basic Information

• Brand Name: REMEL
• Primary DI: 00848838011979
• Version / Model: R08342
• Catalog Number: R08342
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-27
• Public Version: 2
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 1ac3f18c-ec51-4da6-9e3c-51f47a35291e
• Distribution End Date: 2023-01-23

Device Description

DNase Test Agar, Methyl Green(slant)20/PK

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSF	Culture Media, Single Biochemical Test	Microbiology	866.2320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33365	Culture medium control	A device that consists of paper discs, or other suitable material, each impregnated with a specific freeze-dried, viable microorganism used to determine if a given culture medium is able to support the growth of that microorganism.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838011979	GS1