FDA UDI
In Commercial Distribution
🇺🇸 United States
VISERA ELITE II VIDEO SYSTEM CENTER
DI: 04953170386022
·
Model: OLYMPUS OTV-S200
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VISERA ELITE II VIDEO SYSTEM CENTER
- Primary DI
- 04953170386022
- Version / Model
- OLYMPUS OTV-S200
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-12
- Public Version
- 7
- Public Version Date
- 2022-12-12
- Public Version Status
- Update
- Public Device Record Key
- 7176866c-a260-45b0-9532-a8c82f0e01cf
Device Description
VISERA ELITE II VIDEO SYSTEM CENTER
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 |
|---|---|---|---|---|
| OWN | Confocal Optical Imaging | Gastroenterology, Urology | 876.1500 | 2 |
| FET | Endoscopic video imaging system/component, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
| NWB | Endoscope, accessories, narrow band spectrum | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34540 | Endoscopic video image processing/light source system | A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170386022 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]