Centurion
Sterile Trousseau Tracheal DILATOR(25751
45manufacturers in China registered for this device type
98catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (11), Shanghai (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Anhui Medfaith Medical Devices Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 6 |
| Shanghai Kohope Medical Devices Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 45. All 45 manufacturers in China registered for Instrument, Surgical, Disposable
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | KDC |
| Device type | Instrument, Surgical, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-01-01 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 5, case of 50, case of 12, case, case of 10 |
| Distribution end date | 2026-07-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I68615 | In distribution | |
| I68515 | In distribution | |
| I86500 | In distribution | |
| SUT14735 | In distribution | |
| I68805 | In distribution | |
| I68400 | In distribution | |
| BEL46ST | In distribution | |
| I68395 | In distribution | |
| DEP5000ST | In distribution | |
| 66225 | In distribution | |
| 67800 | In distribution | |
| I86695 | In distribution | |
| I68385 | In distribution | |
| 67780 | In distribution | |
| TRKINSTBD1 | In distribution | |
| I68205 | In distribution | |
| I68500 | In distribution | |
| I68305 | In distribution | |
| 67265 | In distribution | |
| 67595 | In distribution | |
| 66735 | In distribution | |
| I68590 | In distribution | |
| I68840 | In distribution | |
| I86735 | In distribution | |
| I68190 | In distribution | |
| STSNWIRE | In distribution | |
| I68165 | In distribution | |
| I68895 | In distribution | |
| 66900 | In distribution | |
| MNS12355 | In distribution | |
| I68645 | In distribution | |
| I68360 | In distribution | |
| I68715 | In distribution | |
| 60210 | In distribution | |
| SR60857A | In distribution | |
| I86880 | In distribution | |
| EB32 | In distribution | |
| I68735 | In distribution | |
| I69005 | In distribution | |
| I68775 | In distribution | |
| SUT21285 | In distribution | |
| I68650 | In distribution | |
| I86890 | In distribution | |
| AM50A | In distribution | |
| I68465 | In distribution | |
| I68115 | In distribution | |
| 67795 | In distribution | |
| I86795 | In distribution | |
| MNH70935MB | In distribution | |
| 67790 | In distribution | |
| 66495 | In distribution | |
| I67995 | In distribution | |
| I67350 | In distribution | |
| I68405 | In distribution | |
| 66810 | In distribution | |
| I68850 | In distribution | |
| I68560 | In distribution | |
| I86875 | In distribution | |
| I68825 | In distribution | |
| MNS10460 | In distribution | |
| I68770 | In distribution | |
| I68020 | In distribution | |
| I67685 | In distribution | |
| MNS11640 | In distribution | |
| I68870 | In distribution | |
| I68780 | In distribution | |
| 66565 | In distribution | |
| I68160 | In distribution | |
| I67870K | In distribution | |
| I68460 | In distribution | |
| I68205 | In distribution | |
| I67980 | In distribution | |
| I68200 | In distribution | |
| I67695 | In distribution | |
| I68000 | In distribution | |
| 67110 | In distribution | |
| NC4100ST | In distribution | |
| I68600 | In distribution | |
| 67420 | In distribution | |
| BLCA15ST | In distribution | |
| I67765 | In distribution | |
| 67285 | In distribution | |
| MNS11890 | In distribution | |
| I68810 | In distribution | |
| I68415 | In distribution | |
| I68300 | In distribution | |
| 67365 | In distribution | |
| MNS11365 | In distribution | |
| I68210 | In distribution | |
| TRKINSTBD2 | In distribution | |
| SUT20490 | In distribution | |
| 66455 | In distribution | |
| I86540 | In distribution | |
| I86895 | In distribution | |
| I67765 | In distribution | |
| I68740 | In distribution | |
| I86885 | In distribution | |
| 589784ST | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 213 |
| DeRoyal | Deroyal Industries, Inc. | 167 |
| Medical Action Industries | Medical Action Industries, Inc. | 112 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 77 |
| Sterion® Vessel Loop | Aspen Surgical Products, Inc. | 47 |
| Sterion®Clamp Cover Fabric | Aspen Surgical Products, Inc. | 31 |
| Integra | Provision | 26 |
| Devon | Cardinal Health | 25 |
| Instrument, Surgical, Disposable | Summit Medical LLC | 23 |
| Dermapac, Inc. | Dermapac Inc. | 22 |
| CareFusion 2200 | Provision | 20 |
| Medline | Medline Industries, Inc. | 20 |
Showing 12 of 155. All products under Instrument, Surgical, Disposable
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-04-09 | Class II | Under Investigation by firm | Three is the potential for the retractors to puncture through the sterile packaging. | 840 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 60075 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.