FDA UDI
In Commercial Distribution
🇺🇸 United States
HardyDisk™
DI: 00816576027200
·
Model: Z9491
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- HardyDisk™
- Primary DI
- 00816576027200
- Version / Model
- Z9491
- Catalog Number
- Z9491
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-08-08
- Public Version
- 1
- Public Version Date
- 2025-08-18
- Public Version Status
- New
- Public Device Record Key
- c7681e0d-cc66-45db-a22e-8d707101c08f
Device Description
HardyDisk™ AST Gepotidacin, 10ug (GEP10), 1x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin.
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 |
|---|---|---|---|---|
| 35733 | Antimicrobial sensitivity disc dispenser IVD | A manually-operated IVD intended to be used for the storage and/or dispensing of antimicrobial sensitivity discs impregnated with antimicrobial agents onto agar or other culture media, for the antimicrobial susceptibility testing of culture isolates from clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00816576027088 | GS1 | ||||
| Primary | 00816576027200 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250956 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 8 Degrees Celsius