HardyDisk™

Basic Information

• Brand Name: HardyDisk™
• Primary DI: 00816576029136
• Version / Model: Z8411
• Catalog Number: Z8411
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-04-26
• Public Version: 2
• Public Version Date: 2023-07-07
• Public Version Status: Update
• Public Device Record Key: ea7c81a9-0482-4fab-814e-4ed95dbcb227

Device Description

Colistin, 10mcg, CT, for the differentiation of anaerobic bacteria based on susceptibility to Colistin, 1 x 50 disks, used as an aid in clarifying gram stain reaction of anaerobes, and in preliminary grouping of anaerobic gram-negative bacilli.

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
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42739	Multiple anaerobic bacteria species culture isolate differentiation disc IVD	One or multiple diagnostic discs impregnated with a range of test reagents intended to be used in microbial testing for the presumptive identification of anaerobic bacteria isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816576029129	GS1
Primary	00816576029136	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius