Inro Surgical Nail
Nail splint for the reconstructive surgery of the nail bed.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Hangzhou GspMed Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Anertai Industrial Limited | Dongguan | Guangdong | Exporter | 12 |
Record
| Listed by | Inro Medical Designs, Inc., United States |
|---|---|
| FDA product code | FYH |
| Device type | Splint, Extremity, Noninflatable, External, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Manufacturer |
| Record published | 2023-08-17 |
| Record revised | 2024-12-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Form filled seal |
| Sizes | Width 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-4R | Width 14 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plastalume | Brownmed | 25 |
| Nice Stretch | Brownmed | 19 |
| Jelco | ICU Medical, Inc | 10 |
| SC | Allied Medical LLC | 9 |
| Dale Bendable Armboard | Dale Medical Products, Inc. | 8 |
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.