Aesculap
CHALLENGER TI Clip Applier Forceps, multi-fire, (310 mm), diam. 5 mm, consisting of PL510R, PL522R, reusable, reposable, to be usedwith: PL572T
9manufacturers in China registered for this device type
46catalogue numbers in this listing
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | GDO |
| Device type | Applier, Surgical, Clip |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-24 |
| Record revised | 2022-11-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2026-03-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PL818R | Diameter (mm) : 12.000 MM | In distribution |
| PL817R | Diameter (mm) : 10.000 MM | In distribution |
| PL828R | Diameter (mm) : 12.000 MM | In distribution |
| MG461R | In distribution | |
| PL602R | In distribution | |
| PL826R | Diameter (mm) : 10.000 MM | In distribution |
| FB223R | In distribution | |
| FB227R | In distribution | |
| PL512R | Working length (mm) : 310.000 MM | In distribution |
| FB257R | In distribution | |
| FB243R | In distribution | |
| PL822R | Diameter (mm) : 5.000 MM | In distribution |
| FB254R | In distribution | |
| PL601R | Working length (mm) : 205.000 MM | In distribution |
| FB256R | In distribution | |
| PL809R | Working length (mm) : 310.000 MM | In distribution |
| FB224R | In distribution | |
| FB249R | In distribution | |
| PL827R | Diameter (mm) : 10.000 MM | In distribution |
| FB246R | In distribution | |
| PL802R | Working length (mm) : 310.000 MM | In distribution |
| PL816R | Working length (mm) : 310.000 MM | In distribution |
| FB282R | In distribution | |
| FB242R | In distribution | |
| PL801R | Working length (mm) : 310.000 MM | In distribution |
| FB226R | In distribution | |
| FB222R | In distribution | |
| FB251R | In distribution | |
| FB255R | In distribution | |
| PL600R | Working length (mm) : 205.000 MM | In distribution |
| FB248R | In distribution | |
| PL808R | Diameter (mm) : 12.000 MM | In distribution |
| FB252R | In distribution | |
| FB240R | In distribution | |
| PL807R | Diameter (mm) : 10.000 MM | In distribution |
| FB245R | In distribution | |
| FB253R | In distribution | |
| PL504R | Diameter (mm) : 10.000 MM | In distribution |
| PL806R | Working length (mm) : 310.000 MM | In distribution |
| XG106R | Withdrawn | |
| XG108R | Withdrawn | |
| XG105R | Withdrawn | |
| XG104R | Withdrawn | |
| XG126R | Withdrawn | |
| XG103R | Withdrawn | |
| XG107R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 996 |
| Teleflex | Teleflex Medical LLC | 61 |
| 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
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.