FDA UDI
In Commercial Distribution
🇺🇸 United States
Angle rotor
DI: 04050674084871
·
Model: 8-place
·
Andreas Hettich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Angle rotor
- Primary DI
- 04050674084871
- Version / Model
- 8-place
- Catalog Number
- 1551
- Company Name
- Andreas Hettich GmbH & Co. KG
- Labeler DUNS
- 316403245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-02
- Public Version
- 1
- Public Version Date
- 2021-09-10
- Public Version Status
- New
- Public Device Record Key
- 4a9e8c6d-367a-4068-8098-52b2cc01e90d
Device Description
Centrifuge rotor fixed angle, 8-place
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GKG | Centrifuge, Hematocrit | Hematology | 864.6400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37532 | Centrifuge rotor, fixed angle | A device, commonly called the rotor, or rotor head, used as a component in a centrifuge. It is designed with the tube holding bores formed at a pre-set angle and pattern. It is horizontally attached at the top of the vertical shaft which is part of the electrically-powered drive unit and the samples to be centrifuged are placed in this rotor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04050674084871 | GS1 |