HardyDisk™

Basic Information

• Brand Name: HardyDisk™
• Primary DI: 00819398020732
• Version / Model: Z9461
• Catalog Number: Z9461
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-11-21
• Public Version: 1
• Public Version Date: 2023-11-29
• Public Version Status: New
• Public Device Record Key: 3b3773a0-16a7-4b50-a866-a20030c8eebe

Device Description

Sulbactam / Durlobactam 10 /10 µg (SUD20), 1 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby- Bauer) of rapidly growing and certain fastidious bacterial pathogens when there is the need to determine the susceptibility of microorganisms to Sulbactam / Durlobactam. Product can be used to determine the zone diameter (mm) of Sulbactam / Durlobactam against the following microorganisms for which Sulbactam / Durlobactam has been shown to be active both clinically and in vitro: Acinetobacter baumannii-calcoaceticus complex (ABC).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	866.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63834	Antibacterial susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398020725	GS1
Primary	00819398020732	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231568	000

Storage Conditions

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