Turbett Surgical
Ground Loader Cart (Includes loading mechanism)
38manufacturers in China registered for this device type
30catalogue numbers in this listing
4510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (9), Shanghai (5). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| Wuhan Zonsen Medical Products Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 24 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Binzhou Dingyue Clothing Company Limited | Binzhou | Shandong | Contract manufacturer | 7 |
Showing 12 of 38. All 38 manufacturers in China registered for Wrap, Sterilization
Record
| Listed by | Turbett Surgical, Inc, United States |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-04-25 |
| Record revised | 2025-11-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS2051 | In distribution | |
| TS3025 | In distribution | |
| TS1000 | In distribution | |
| TS2011 | In distribution | |
| TS2056 | In distribution | |
| TS2044 | In distribution | |
| TS2047 | In distribution | |
| TS3080 | In distribution | |
| TS1500 | In distribution | |
| TS3070 | In distribution | |
| TS2020 | In distribution | |
| TS2036 | In distribution | |
| TS2045 | In distribution | |
| TS3035 | In distribution | |
| TS3044 | In distribution | |
| TS2053 | In distribution | |
| TS2015 | In distribution | |
| TS1200 | In distribution | |
| TS3020 | In distribution | |
| TS3015 | In distribution | |
| TS2030 | In distribution | |
| TS2038 | In distribution | |
| TS3041 | In distribution | |
| TS2025 | In distribution | |
| TS2052 | In distribution | |
| TS2039 | In distribution | |
| TS3085 | In distribution | |
| TS3010 | In distribution | |
| TS2055 | In distribution | |
| TS2037 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 824 |
| Cardinal Health | Cardinal Health 200, LLC | 333 |
| Arjo Wiggins Medical, Inc. | Sterimed, Inc. | 286 |
| Halyard | O&M Halyard, Inc. | 191 |
| Primed | Primed Medical Products Inc. | 154 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 148 |
| Vivit Supply | Vivit Supply LLC | 103 |
| Case Medical | Case Medical, Inc. | 103 |
| Gemini | Medline Industries, Inc. | 89 |
| CareGUARD | Care Essentials PTY Ltd | 72 |
| Halyard | Owens & Minor Distribution, Inc. | 70 |
| Wrap, Sterilization | Steris Corporation | 69 |
Showing 12 of 232. All products under Wrap, Sterilization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250011 | 2025-04-04 |
| K202593 | 2021-05-19 |
| K200240 | 2020-04-30 |
| K153025 | 2016-01-14 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Turbett Surgical, Inc | UDI-DI | 2022-12-05 | Class II | Device Design | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. | 61 units | |
| Turbett Surgical, Inc | UDI-DI | 2022-12-05 | Class II | Device Design | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. | 6 units | |
| Turbett Surgical, Inc | UDI-DI | 2022-04-14 | Class II | Process control | Devices were subject to unapproved rework processes. | 7 units | 2025-02-20 |
| Turbett Surgical, Inc | UDI-DI | 2022-04-01 | Class II | Device Design | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. | 232 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.