Centurion
IUD Insertion KIT
1manufacturer
14catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | KNA |
| Device type | Instrument, Manual, Specialized Obstetric-Gynecologic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2016-09-13 |
| Record revised | 2022-06-17 (version 4) |
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 5, case of 10, case of 20, case of 6, case of 50, case of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HUD56ST | In distribution | |
| NSB83360 | In distribution | |
| MNS12100 | In distribution | |
| MNS12335 | In distribution | |
| HUD910ST | In distribution | |
| 68790 | In distribution | |
| MNS9335 | In distribution | |
| TOC800 | In distribution | |
| HUD78ST | In distribution | |
| HUD112ST | In distribution | |
| PE3620 | In distribution | |
| HUD12ST | In distribution | |
| 67465 | In distribution | |
| PE3495 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kirwan | Kirwan Surgical Products, LLC. | 33 |
| Pilling | Teleflex Medical LLC | 15 |
| Cyst Puncture Needle with Stylet | Vitrolife Sweden AB | 12 |
| Cyst Puncture Needle without Stylet | Vitrolife Sweden AB | 7 |
| Alexis ® O C-Section Protector-Retractor | Applied Medical Resources Corp. | 4 |
| Tenacath | Cook Incorporated | 2 |
| Bioteque | Bioteque Taiwan Ltd. | 2 |
| Obstetrical Kit | Dynarex Corp. | 2 |
| Cook | Cook Incorporated | 2 |
| Pro-Ception | Coopersurgical, Inc. | 2 |
| Gynex | Gynex Corporation | 1 |
| Cordguard® | Utah Medical Products, Inc. | 1 |
Showing 12 of 19. All products under Instrument, Manual, Specialized Obstetric-Gynecologic
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.