Disposable Head Halter
Catalogue number 342-2, listed by Mizuho Orthopedic Systems, Inc., United States, under Halter, Head, Traction. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (2), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Changzhou Well Lands Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| A & I Industries Ltd | Foshan | Guangdong | Manufacturer | 35 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Zhongshan A&E Machinery Industry Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 25 |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang | Liaoning | Manufacturer | 24 |
Record
| Listed by | Mizuho Orthopedic Systems, Inc., United States |
|---|---|
| FDA product code | HSS |
| Device type | Halter, Head, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5890 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-10-17 |
| Record revised | 2021-09-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 342-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Halter, Head, Traction | Zimmer Orthopaedic Surgical Products | 2 |
| Drive | Drive DeVilbiss Healthcare | 1 |
| Halter, Head, Traction | Steris Corporation | 1 |
| Drivemedical | Drive DeVilbiss Healthcare | 1 |
| Assy, Head Halter and Chin Cup | Mizuho Orthopedic Systems, Inc. | 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.