FDA UDI
In Commercial Distribution
🇺🇸 United States
STARLET COMPL. WITH ACCESS.
DI: 07630032600027
·
Model: 185082
·
Hamilton Bonaduz AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STARLET COMPL. WITH ACCESS.
- Primary DI
- 07630032600027
- Version / Model
- 185082
- Company Name
- Hamilton Bonaduz AG
- Labeler DUNS
- 480542497
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-12-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 804f8bc2-5f69-4e4d-b107-fee8555041bb
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | Clinical Chemistry | 862.2750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47832 | Pipetting system | An assembly of devices designed to automatically pipette liquids in the laboratory for the preparation/concentration of analytes (e.g., cells, nucleic acids, microorganisms) in clinical specimens (e.g., blood, urine, sputum, faeces). It is software operated and automatically moves liquids by pipetting, and typically by mixing, heating, and magnetic particle handling. It typically includes a mains electricity (AC-powered) pipetting system, a heating module, shaker, barcode reader (for specimen traceability), adaptors, grippers, and sample racks. The system is commonly used with specialized kits for the extraction/isolation/concentration of analytes. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630032600027 | GS1 |