Sklar
Censitrac Ready Laborde Trach Diltr 3PRG 5 1/2
2manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
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 | Sklar Corporation, United States |
|---|---|
| FDA product code | KCG |
| Device type | Dilator, Tracheal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-03-13 |
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 |
|---|---|---|
| 78-3360 | In distribution | |
| 78-3460C | In distribution | |
| 78-3460 | In distribution | |
| 78-3360C | In distribution |
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 |
| 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 |
| Gimmi | Gimmi Gmbh | 2 |
Showing 12 of 26. All products under Dilator, Tracheal
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 0 units |
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.