FDA UDI
In Commercial Distribution
🇺🇸 United States
SPiN Vision Video Processor
DI: 00815686021320
·
Model: SYS-5100
·
VERAN MEDICAL TECHNOLOGIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SPiN Vision Video Processor
- Primary DI
- 00815686021320
- Version / Model
- SYS-5100
- Catalog Number
- SYS-5100
- Company Name
- VERAN MEDICAL TECHNOLOGIES INC.
- Labeler DUNS
- 181714804
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-11
- Public Version
- 1
- Public Version Date
- 2023-02-20
- Public Version Status
- New
- Public Device Record Key
- b6e63723-5bcc-4e22-b547-3d4a51d06a68
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47140 | Endoscopic control/video-imaging system | A mains electricity (AC-powered) multifunctional device assembly designed to interface with a flexible steerable, self-propelled, or externally-propelled video endoscope (not included) to: 1) control movement of the endoscope (e.g., steer, propel); and 2) receive and process electronic video image signals sent from the endoscope. It includes a controller/control unit, image processor, and may include an image display monitor and light source. It might additionally allow control of insufflation or suction. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815686021320 | GS1 |