N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398022453
• Version / Model: L60
• Catalog Number: L60
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-06-03
• Public Version: 1
• Public Version Date: 2020-06-11
• Public Version Status: New
• Public Device Record Key: dceaa427-41d5-49be-b4a5-0f542a54abb8

Device Description

Tryptic Soy Agar (TSA) Slant, 5.5ml, 16x100mm tube, order by the package of 20 (Tryptic Soy Agar) For the cultivation of microorganisms. For use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance, and transportation of pure cultures of microorganisms.

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: 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
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	866.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious 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	00819398022446	GS1
Primary	00819398022453	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius