FDA UDI
In Commercial Distribution
🇺🇸 United States
KOLPLAST
DI: 07898027908682
·
Model: SOL SALINA 3ML/2SWAB T10 EST
·
Kolplast C I
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KOLPLAST
- Primary DI
- 07898027908682
- Version / Model
- SOL SALINA 3ML/2SWAB T10 EST
- Catalog Number
- 10.4118
- Company Name
- Kolplast C I
- Labeler DUNS
- 903963889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-29
- Public Version
- 1
- Public Version Date
- 2023-12-07
- Public Version Status
- New
- Public Device Record Key
- 5c9ff211-657c-476a-9764-601ca77233b8
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | Microbiology | 866.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58673 | Saline suspension medium/diluent IVD | A saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898027908682 | GS1 |