Performa
Performa Sonishield Antimicrobial Ultrasound Gel 20g tube
8manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Hong Kong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei | Anhui | Contract manufacturer | 16 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Foshan Pingchuang Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Performance Health Supply, Inc., United States |
|---|---|
| FDA product code | MUI |
| Device type | Media, Coupling, Ultrasound |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K151070 |
| Record published | 2017-10-12 |
| Record revised | 2026-03-17 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Weight 20 g; total volume 8.5 Fluid Ounce |
| Distribution end date | 2023-12-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 081710755 | Weight 20 g | 100 | Withdrawn |
| 081710748 | Total Volume 8.5 Fluid Ounce | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Winner EVO Package | Drive DeVilbiss Healthcare | 36 |
| GelShot | Drive DeVilbiss Healthcare | 33 |
| Wavelength | National Therapy Products Inc. | 32 |
| Pharmaceutical Innovations | Pharmaceutical Innovations, Inc. | 27 |
| Therasound EVO Package | Drive DeVilbiss Healthcare | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| EcoVue | HR Pharmaceuticals Inc. | 7 |
| HR Ultrasound Jelly | HR Pharmaceuticals Inc. | 7 |
| Medline | Medline Industries, Inc. | 7 |
| Aquasonic Clear | Parker Laboratories, Inc. | 6 |
| Medichoice | Owens & Minor Distribution, Inc. | 5 |
| Aquasonic | Parker Laboratories, Inc. | 5 |
Showing 12 of 40. All products under Media, Coupling, Ultrasound
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.