FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VISERA VIDEO SYSTEM CENTER
DI: 04953170141546
·
Model: OTV-S7V
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VISERA VIDEO SYSTEM CENTER
- Primary DI
- 04953170141546
- Version / Model
- OTV-S7V
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 7
- Public Version Date
- 2024-01-15
- Public Version Status
- Update
- Public Device Record Key
- ebd2ef7b-af92-4cba-9e9e-27f88d904bb0
- Distribution End Date
- 2024-01-12
Device Description
"OTV-S7V-D VISERA DIGITAL CAMERA PROCESSO"
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 |
|---|---|---|---|---|
| NWB | Endoscope, accessories, narrow band spectrum | Gastroenterology, Urology | 876.1500 | 2 |
| FDS | Gastroscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
| FDF | Colonoscope and accessories, flexible/rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18034 | Endoscopic video image processing unit | An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170141546 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]