FDA UDI
In Commercial Distribution
🇺🇸 United States
VERITON NM
DI: 07290108670103
·
Model: 001
·
SPECTRUM DYNAMICS MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VERITON NM
- Primary DI
- 07290108670103
- Version / Model
- 001
- Catalog Number
- 8010184-01
- Company Name
- SPECTRUM DYNAMICS MEDICAL, INC
- Labeler DUNS
- 078864620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-08
- Public Version
- 1
- Public Version Date
- 2018-12-10
- Public Version Status
- New
- Public Device Record Key
- f34b1d28-1aff-419c-8178-894310d5a2c2
Device Description
Single Photon Emission Computed Tomography System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40643 | SPECT system, annular detector array | An assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system designed exclusively for use in tomographic imaging applications. It detects, records, quantifies and analyses radionuclide emissions produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. The gantry position is fixed and the imaging table/chair moves/rotates under computer or manual control. Its imaging capabilities include static and dynamic imaging applications and three-dimensional (3-D) digital image reconstruction/display at any angle including axial, coronal and sagittal planes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290108670103 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180514 | 000 |