Flyte
Helmet with Battery Powered Headlight
7manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (3), Guangdong (2), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Fofo Medical Co., Ltd. | Xiamen | Fujian | Exporter | 18 |
| Henan Joinkona Medical Products Stock Co., Ltd. | Pingdingshan | Henan | Contract manufacturer | 12 |
| Xianning Full Guard Medical Products Co., Ltd. | Xianning | Hubei | Manufacturer | 10 |
| Hubei Lioncare Protective Products Co., Ltd. | Wuhan | Hubei | Manufacturer | 7 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FXZ |
| Device type | Helmet, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 40 °C; Storage environment humidity 10 to 75 % RH |
| Sizes | Weight 0.47 to 0.68 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0408645000 | Weight 0.52 kg | In distribution |
| 0408655000 | In distribution | |
| 0408635000 | Weight 0.68 kg | In distribution |
| 0408655002 | In distribution | |
| 0408655001 | In distribution | |
| 0408655300 | In distribution | |
| 0408600000 | Weight 0.47 kg | In distribution |
| 0408655200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmet, Surgical | Stryker GmbH | 16 |
| Steri-Shield | Stryker GmbH | 2 |
| Maxair | Syntech, Int’l Inc. | 2 |
| Innomed, Inc. | Innomed, Inc. | 1 |
| ViVi® HELMET25 XL HPL | THI Total Healthcare Innovation Gmbh | 1 |
| ViVi® HELMET25 HPL | THI Total Healthcare Innovation Gmbh | 1 |
| ViVi® HELMET25 | THI Total Healthcare Innovation Gmbh | 1 |
| ViVi® HELMET25 XL | THI Total Healthcare Innovation Gmbh | 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.