FDA UDI
In Commercial Distribution
🇺🇸 United States
ONPG DISCS DD13
DI: 05032384034154
·
Model: DD0013T
·
OXOID LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ONPG DISCS DD13
- Primary DI
- 05032384034154
- Version / Model
- DD0013T
- Company Name
- OXOID LIMITED
- Labeler DUNS
- 365355452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-04
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- a878d88e-7613-4316-9679-2da49fadb011
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34176 | ONPG (ortho-nitrophenyl-beta-galactoside) differentiation disc IVD | One or multiple diagnostic discs impregnated with ortho-nitrophenyl-beta-galactoside (ONPG) reagent intended to be used in microbial testing for the detection of beta-galactosidase activity in microorganisms isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05032384034154 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K832307 | 000 |