Pratt Crypt Hook
Pratt Crypt Hook Narrow Hook/Gauge Wire
4manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | FHB |
| Device type | Hook, Gastro-Urology |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-14 |
| Record revised | 2024-03-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 8.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-0311 | Length 8.5 in | In distribution |
| 90-0313 | Length 8.5 in | In distribution |
| 90-0309 | Length 8.5 in | In distribution |
| 90-0312 | Length 8.5 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical | Novo Surgical, Inc. | 3 |
| Millennium | Avalign Technologies, Inc. | 2 |
| Medline | Medline Industries, Inc. | 1 |
| 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.