FDA UDI
In Commercial Distribution
🇺🇸 United States
VISERA S VIDEO SYSTEM CENTER
DI: 04953170454141
·
Model: OLYMPUS OTV-S500
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VISERA S VIDEO SYSTEM CENTER
- Primary DI
- 04953170454141
- Version / Model
- OLYMPUS OTV-S500
- Catalog Number
- N6214840
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-14
- Public Version
- 3
- Public Version Date
- 2026-02-17
- Public Version Status
- Update
- Public Device Record Key
- 4a666fea-32b8-4367-b638-55526a438cd3
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 |
|---|---|---|---|---|
| NTN | Led Light Source | Gastroenterology, Urology | 876.1500 | 2 |
| NWB | Endoscope, Accessories, Narrow Band Spectrum | Gastroenterology, Urology | 876.1500 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
| EQL | Laryngostroboscope | Ear, Nose, Throat | 874.4750 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 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 | 04953170454141 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]