Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Antimicrobial sensitivity disc dispenser IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Z9491 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- Z9491 FDA UDI
- Primary DI / UDI-DI
- 00816576027200 FDA UDI
- 510(k) Number
- K250956 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Antimicrobial sensitivity disc dispenser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antimicrobial sensitivity disc dispenser IVD
HardyDisk™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antimicrobial sensitivity disc dispenser IVD.
- BD BBL™ Sensi-Disc™ 12-Place Dispenser Cannister — BECTON DICKINSON AND COMPANY · Class II
- BD BBL™ Sensi-Disc™ Single Disc Dispenser — BECTON DICKINSON AND COMPANY · Class I
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
- BD BBL™ Sensi-Disc™ 6-Place Self-Tamping Dispenser — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Sensi-Disc™ Single Disc Dispenser — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Sensi-Disc™ 8-Place Self-Tamping Dispenser — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Sensi-Disc™ 12-Place Self-Tamping Dispenser — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Prompt™ Inoculation System — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
K250956 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI c7681e0d-cc66-45db-a22e-8d707101c08f 37 fields · synced Jun 8, 2026