Teleflex
Applier, Small, Narrow, Long Yellow 11 curved
9manufacturers in China registered for this device type
61catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Tianjin Huahong Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Sinolinks Medical Innovation, Inc. | Changzhou | Jiangsu | Complaint-file establishment | 5 |
| Fengh Medical Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GDO |
| Device type | Applier, Surgical, Clip |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-10-31 |
| Record revised | 2026-02-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 20, box of 14 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN055309 | In distribution | ||
| IPN055344 | In distribution | ||
| IPN055341 | In distribution | ||
| IPN055316 | In distribution | ||
| IPN055304 | In distribution | ||
| IPN055314 | In distribution | ||
| IPN055324 | 6 | In distribution | |
| IPN055326 | In distribution | ||
| 71114V | 6 | In distribution | |
| IPN055321 | In distribution | ||
| IPN055331 | In distribution | ||
| IPN055310 | In distribution | ||
| IPN055300 | In distribution | ||
| IPN055306 | In distribution | ||
| IPN055329 | In distribution | ||
| IPN055351 | In distribution | ||
| IPN055390 | In distribution | ||
| IPN055318 | In distribution | ||
| IPN055342 | In distribution | ||
| IPN055391 | In distribution | ||
| IPN055334 | In distribution | ||
| IPN055340 | In distribution | ||
| IPN055336 | In distribution | ||
| IPN055297 | In distribution | ||
| IPN055338 | In distribution | ||
| IPN055301 | In distribution | ||
| IPN055346 | In distribution | ||
| IPN055392 | In distribution | ||
| IPN055311 | In distribution | ||
| IPN055315 | In distribution | ||
| IPN055328 | In distribution | ||
| IPN055352 | In distribution | ||
| IPN055345 | In distribution | ||
| IPN055320 | In distribution | ||
| IPN055335 | In distribution | ||
| IPN055339 | In distribution | ||
| IPN055322 | In distribution | ||
| IPN055313 | In distribution | ||
| IPN055317 | In distribution | ||
| IPN055337 | In distribution | ||
| IPN055303 | In distribution | ||
| IPN926203 | 6 | In distribution | |
| IPN055343 | In distribution | ||
| IPN055333 | In distribution | ||
| IPN055332 | In distribution | ||
| IPN055302 | In distribution | ||
| IPN055319 | In distribution | ||
| IPN055305 | In distribution | ||
| IPN055347 | In distribution | ||
| IPN055327 | In distribution | ||
| IPN055350 | In distribution | ||
| IPN055299 | In distribution | ||
| IPN055323 | In distribution | ||
| IPN055348 | In distribution | ||
| IPN055308 | In distribution | ||
| IPN055330 | In distribution | ||
| IPN055307 | In distribution | ||
| IPN055298 | In distribution | ||
| IPN055312 | In distribution | ||
| IPN921002 | 6 | In distribution | |
| IPN055349 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 996 |
| Aesculap | Aesculap AG | 46 |
| Ligaclip | Ethicon Endo-Surgery, Inc. | 29 |
| Surgical Direct | Surgical Direct, Inc. | 28 |
| Elmed | Elmed, Inc. | 23 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 19 |
| Ambler Surgical | Ambler Surgical, LLC | 19 |
| Europclip | Ackermann Instrumente Gmbh | 17 |
| Lazic | Peter Lazic Gmbh | 15 |
| Artisential Clip Applier Large | LivsMed Inc. | 14 |
| Artisential Clip Applier Medium Large | LivsMed Inc. | 14 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 11 |
Showing 12 of 73. All products under Applier, Surgical, Clip
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 | Closed |
|---|---|---|---|---|---|
| 2016-08-24 | Class II | Error in labeling | Misbranded: Incorrect etching on the device. | 49 units | 2017-08-25 |
| 2003-05-21 | Not classified | Other | Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment. | 667 units | 2005-01-31 |
| 2001-10-31 | Not classified | Other | The flush port on some appliers was occluded with an epoxy resin during manufacturing. | 66 units | 2005-01-31 |
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.