Centurion
Hank Uterine Dilator 11' 13/14FR Sterile
3manufacturers in China registered for this device type
6catalogue 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 |
| Wenzhou LW Wewear Accessories Co., Ltd. | Wenzhou | Zhejiang | Private-label distributor | 2 |
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2022-03-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I68920 | In distribution | |
| I68925 | In distribution | |
| HUD34ST | In distribution | |
| HUD1314ST | In distribution | |
| I68915 | In distribution | |
| I68930 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hayden Medical | Hayden Medical Inc | 184 |
| Millennium | Avalign Technologies, Inc. | 181 |
| Elmed Incorporated | Elmed, Inc. | 152 |
| Marina Medical | Marina Medical Instruments, Inc. | 142 |
| Elmed | Elmed, Inc. | 138 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 129 |
| Ambler Surgical | Ambler Surgical, LLC | 103 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 100 |
| Aesculap | Aesculap AG | 98 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 77 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 73 |
| V. Mueller | Steris Corporation | 65 |
Showing 12 of 104. All products under Dilator, Cervical, Fixed Size
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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. | 270 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.