Otopront
4 catalogue numbers from PES Pilot HDpro, listed by Happersberger Otopront Gmbh, Germany, under Camera, Television, Surgical, With Audio. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue 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 | Happersberger Otopront Gmbh, Germany |
|---|---|
| FDA product code | FWC |
| Device type | Camera, Television, Surgical, With Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-04 |
| Record revised | 2025-06-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PES Pilot HDpro | In distribution | |
| PES Pilot HDpro | In distribution | |
| PES Eco HD | In distribution | |
| PES Eco HD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® | Integra Lifesciences (Ireland) Limited | 4 |
| Integra® | Integra LifeSciences Production Corporation | 2 |
| 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.