PTL-Retractor System
External Medial/Lateral Blade Holder
34manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Medicrea International, France |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-31 |
| Record revised | 2022-12-01 (version 5) |
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, expiry date |
| Distribution end date | 2021-10-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A18101880 | Withdrawn | |
| A18000000 | Withdrawn | |
| A18101850 | Withdrawn | |
| A18000600 | Withdrawn | |
| A18102280 | Withdrawn | |
| A18000500 | Withdrawn | |
| A18101860 | Withdrawn | |
| A18101200 | Withdrawn | |
| A18000300 | Withdrawn | |
| A18000210 | Withdrawn | |
| A18101870 | Withdrawn | |
| A18104100 | Withdrawn | |
| A18101260 | Withdrawn | |
| A18101250 | Withdrawn | |
| A18000100 | Withdrawn | |
| A18103100 | Withdrawn | |
| A18102160 | Withdrawn | |
| A18102260 | Withdrawn | |
| A18101280 | Withdrawn | |
| A18101270 | Withdrawn | |
| A18101290 | Withdrawn | |
| A18101800 | Withdrawn | |
| A18000240 | Withdrawn | |
| A18102180 | Withdrawn | |
| A18101890 | Withdrawn | |
| A18000220 | Withdrawn | |
| A18102100 | Withdrawn | |
| A18000400 | Withdrawn | |
| A18102200 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
Showing 12 of 2,238. All products under Retractor
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.