FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermo Scientific
DI: 10850685007682
·
Model: Sorvall Legend Micro 21R
·
Thermo Electron LED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thermo Scientific
- Primary DI
- 10850685007682
- Version / Model
- Sorvall Legend Micro 21R
- Catalog Number
- 75002446
- Company Name
- Thermo Electron LED GmbH
- Labeler DUNS
- 537396330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-11
- Public Version
- 1
- Public Version Date
- 2022-07-19
- Public Version Status
- New
- Public Device Record Key
- aa21d6d4-7e8d-41c8-8bc5-6f37f73310ec
Device Description
Sorvall Legend Micro 21R 120V/60Hz
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 |
|---|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17452 | Microsample centrifuge IVD | An electrically-powered device intended to be used mainly in the clinical laboratory to centrifuge small sample volumes (typically from 0.25 to 2.2 ml) through centrifugal force. It is typically a compact stationary structure with an electric motor, a rotor, a shaft, and speed and time controls. It may include a vortex mixing function and/or refrigerating capabilities to keep cool the rotor chamber or to perform temperature sensitive procedures. The device is intended to spin down microorganisms, cells, precipitates, or reagent solutions prior to subsequent in vitro diagnostic procedures; it may also sediment viruses and cellular organelles. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850685007682 | GS1 |
Customer Contacts
- Phone
- +496184906000
- [email protected]