Integra®
Fixed Focus Headlight Camera System (NTSC) Camera Control Unit ONLY
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | FWC |
| Device type | Camera, Television, Surgical, With Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-13 |
| Record revised | 2021-01-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 500 to 1060 millibar; Storage environment temperature 0 to 50 °C; Storage environment humidity 10 to 85 % RH; Special storage condition: Keep Dry |
| Distribution end date | 2020-03-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 003285CCNTSC | Withdrawn | |
| 003285HLNTSC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Otopront | Happersberger Otopront Gmbh | 4 |
| Integra® | Integra Lifesciences (Ireland) Limited | 4 |
| VoirElite 4K 31.5 Surgical Display | JAM-Labs Corp | 1 |
| Medical Facets NC | Medical Facets NC LLC | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.