FDA UDI
In Commercial Distribution
🇺🇸 United States
HardyDisk™
DI: 00816576027194
·
Model: Z9495
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
250
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Basic Information
- Brand Name
- HardyDisk™
- Primary DI
- 00816576027194
- Version / Model
- Z9495
- Catalog Number
- Z9495
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- 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
- 1222ac4e-1448-48bd-9323-5fe1845fddf9
Device Description
HardyDisk™ AST Gepotidacin, 10ug (GEP10), 5 x 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 | 00816576027194 | 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