Centurion
Sterile Strt Iris Scissor (IS163K) Repro
83manufacturers in China registered for this device type
63catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (36), Jiangsu (20), Guangdong (7). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Taizhou Xinkang Medical Materials Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 35 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Suzhou Vicon Industrial Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Zhejiang Tiansong Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Yangjiang City YUE Cheng Industry AND Trade Co., Ltd. | Yangjiang | Guangdong | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 83. All 83 manufacturers in China registered for Scissors, General, Surgical
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | LRW |
| Device type | Scissors, General, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-01-01 |
| Record revised | 2022-09-23 (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 500 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I68575 | In distribution | |
| I68750 | In distribution | |
| 66155K | In distribution | |
| I68790 | In distribution | |
| 66610 | In distribution | |
| 66820K | In distribution | |
| I69015 | In distribution | |
| 65945 | In distribution | |
| TRI67630 | In distribution | |
| 66895 | In distribution | |
| 66610K | In distribution | |
| 66665 | In distribution | |
| TRI66540 | In distribution | |
| 66365 | In distribution | |
| I67500 | In distribution | |
| 65145 | In distribution | |
| 11109SBMB | In distribution | |
| 67185 | In distribution | |
| 66215 | In distribution | |
| 66155 | In distribution | |
| I69050 | In distribution | |
| I68495 | In distribution | |
| 66710 | In distribution | |
| TRI66540K | In distribution | |
| 67025 | In distribution | |
| TRI66600 | In distribution | |
| I68510 | In distribution | |
| 66155K | In distribution | |
| 67645 | In distribution | |
| I69045 | In distribution | |
| 66995 | In distribution | |
| 67935 | In distribution | |
| 66885 | In distribution | |
| 66150K | In distribution | |
| 66260 | In distribution | |
| 67640 | In distribution | |
| 66530 | In distribution | |
| 67000 | In distribution | |
| IS163SMB | In distribution | |
| 66845 | In distribution | |
| 66530K | In distribution | |
| 66150 | In distribution | |
| TRI66670K | In distribution | |
| IC164SMB | In distribution | |
| 67650 | In distribution | |
| 66675 | In distribution | |
| 65940K | In distribution | |
| 66350 | In distribution | |
| TRI66540K | In distribution | |
| 66450 | In distribution | |
| 66465 | In distribution | |
| 67165 | In distribution | |
| 67450 | In distribution | |
| 67160 | In distribution | |
| 65940 | In distribution | |
| 66610K | In distribution | |
| 66890 | In distribution | |
| I66365K | In distribution | |
| I68165K | In distribution | |
| 66820 | In distribution | |
| 65940K | In distribution | |
| I68165K | In distribution | |
| I66855K | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 1,579 |
| Peak Medical | Peak Medical Distribution Inc | 868 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 808 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 748 |
| Ambler Surgical | Ambler Surgical, LLC | 720 |
| Millennium | Avalign Technologies, Inc. | 642 |
| Surtex | Surtex Instruments Ltd | 576 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 558 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 524 |
| HNM Medical | HNM Stainless, LLC. | 523 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 495 |
| Aesculap | Aesculap AG | 488 |
Showing 12 of 796. All products under Scissors, General, Surgical
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. | 568,849 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.