FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermo Scientific
DI: 10850033408307
·
Model: Sorvall X4R Pro-MD
·
Thermo Electron LED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thermo Scientific
- Primary DI
- 10850033408307
- Version / Model
- Sorvall X4R Pro-MD
- Catalog Number
- 75009520
- 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
- a2b2d0c8-a0e3-4e8d-8abc-be82f312eff9
Device Description
Sorvall X4R Pro-MD 220-240/230V/50/60Hz
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 |
|---|---|---|---|---|
| 36465 | General-purpose centrifuge IVD | An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850033408307 | GS1 |
Customer Contacts
- Phone
- +496184906000
- [email protected]