GPS
Barrier Envelopes Size 1
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Guangdong Yuehua Medical Instrument Factory Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | Group Practice Solutions, United States |
|---|---|
| FDA product code | IXC |
| Device type | Illuminator, Radiographic-Film |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1890 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2016-12-05 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45-8800 | In distribution | |
| 45-8700 | In distribution | |
| 45-8900 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Defend | Young Mydent, LLC | 6 |
| Porta-View™ | Innovative Medical Products, Inc. | 4 |
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.