Sklar®
Censitrac Ready News Tracheal Hook 6"
3manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hangzhou Alline Plastic Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | KCH |
| Device type | Hook, Tracheal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-11-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 78-3545 | In distribution | |
| 78-3522 | In distribution | |
| 78-3527 | In distribution | |
| 78-3545C | In distribution | |
| 78-3523 | In distribution | |
| 78-3528 | In distribution | |
| 78-3524 | In distribution | |
| 78-3525 | In distribution | |
| 78-3526 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 9 |
| Boss Instruments | Boss Instruments, Ltd. | 8 |
| Millennium | Avalign Technologies, Inc. | 7 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 7 |
| Avalign | Avalign Technologies, Inc. | 7 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 5 |
| Aesculap | Aesculap AG | 5 |
| Symmetry Cottle | Aspen Surgical Products, Inc. | 4 |
| V. Mueller | Steris Corporation | 4 |
| Pilling | Teleflex Medical LLC | 4 |
| Gimmi | Gimmi Gmbh | 3 |
Showing 12 of 30. All products under Hook, Tracheal
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.