Single Use Surgical Professional
Tracheal Dilator
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Shandong (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 |
Record
| Listed by | Eakin Surgical Ltd, United Kingdom |
|---|---|
| FDA product code | KCG |
| Device type | Dilator, Tracheal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-09 |
| Record revised | 2023-10-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 15 |
| Distribution end date | 2023-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S181 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 22 |
| InHealth Technologies; Blom-Singer | Freudenberg Medical, LLC | 7 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 4 |
| V. Mueller | Steris Corporation | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| Sklar | Sklar Corporation | 4 |
| Millennium | Avalign Technologies, Inc. | 3 |
| Boss Instruments | Boss Instruments, Ltd. | 3 |
| Symmetry Trousseau | Aspen Surgical Products, Inc. | 3 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 3 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 3 |
| Trousseau Tracheal Dilator Retractor | Sontec Instruments, Inc. | 3 |
Showing 12 of 26. All products under Dilator, 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.