Medline
Disimpactor, Fecal Impaction, Medline
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FHB |
| Device type | Hook, Gastro-Urology |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Premarket notification | Exempt |
| Record published | 2024-04-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FMDIS01 | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pratt Crypt Hook | Sontec Instruments, Inc. | 4 |
| Novo Surgical | Novo Surgical, Inc. | 3 |
| Millennium | Avalign Technologies, Inc. | 2 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 1 |
| V. Mueller | Steris Corporation | 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.