Lone Star
Lone Star Disposable retractor ring with 2 catheter clips ; 32.5 cm x 18.3 cm
34manufacturers in China registered for this device type
45catalogue numbers in this listing
1recall
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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2022-10-30 |
| Record revised | 2026-07-23 (version 5) |
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 |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 5, 02 of 72, 2 of 50, 02 of 50, pack of 50, case of 50 |
| Sizes | Outer diameter 8.9 to 32.5 cm; tip bend radius 3 to 12 mm; length 13 to 20 mm; width 6.5 to 20 mm; weight 77 to 795 g; length 24.3 cm; width 24.3 cm |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3332- 4G | Length 16 mm | In distribution |
| DMI-12G | In distribution | |
| 3310G | Outer Diameter 25 cm | In distribution |
| 3325-4G | Tip Bend Radius 5 mm | In distribution |
| 2200 | Outer Diameter 27.5 cm | In distribution |
| 3330-4G | Length 13 mm | In distribution |
| 3302G | Outer Diameter 22 cm | In distribution |
| 3329-4G | Tip Bend Radius 9 mm | In distribution |
| 3335-4G | Width 20 mm | In distribution |
| 3707 | Outer Diameter 25 cm | In distribution |
| 3301G | Outer Diameter 25.3 cm | In distribution |
| 3309G | Outer Diameter 18.6 cm | In distribution |
| 3331-4G | Length 13 mm | In distribution |
| 3350L-4G | Tip Bend Radius 12 mm | In distribution |
| 3611 | In distribution | |
| 3314-1G | Tip Bend Radius 3 mm | In distribution |
| 1104 | Outer Diameter 32.2 cm | In distribution |
| 3308G | Outer Diameter 28.3 cm | In distribution |
| 3311-1G | Tip Bend Radius 5 mm | In distribution |
| 3550-1G | Tip Bend Radius 12 mm | In distribution |
| 3316-8G | Tip Bend Radius 5 mm | In distribution |
| 72403867 | In distribution | |
| 2201 | Outer Diameter 16.4 cm | In distribution |
| 3350-8G | Tip Bend Radius 12 mm | In distribution |
| 3334-4G | Length 20 mm | In distribution |
| 3384-4 | Tip Bend Radius 12 mm | In distribution |
| 3333- 4G | Length 20 mm | In distribution |
| 3704 | Outer Diameter 25 cm | In distribution |
| 3314-8G | Tip Bend Radius 3 mm | In distribution |
| 1110 | Length 24.3 cm | In distribution |
| 3304G | Outer Diameter 32.5 cm | In distribution |
| 3316-1G | In distribution | |
| 3205-8G | Tip Bend Radius 5 mm | In distribution |
| 1103 | Outer Diameter 11.6 cm | In distribution |
| 3350-1G | Tip Bend Radius 12 mm | In distribution |
| 3650 | In distribution | |
| 3338-4G | Length 16 mm | In distribution |
| 3311-8G | Tip Bend Radius 5 mm | In distribution |
| 3307G | Outer Diameter 14.1 cm | In distribution |
| 3715 | Outer Diameter 16.5 cm | In distribution |
| 3327-4G | Tip Bend Radius 7 mm | In distribution |
| 91167705-01 | Tip Bend Radius 12 mm | Withdrawn |
| 3304G-AMS | Outer Diameter 32.5 cm | Withdrawn |
| 91167709-01 | Outer Diameter 32 cm | Withdrawn |
| 3350-8G-AMS | Tip Bend Radius 12 mm | 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
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 |
|---|---|---|---|---|---|
| 2018-09-04 | Class II | Nonconforming Material/Component | There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. | 18,000 units | 2020-04-15 |
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.