Medline ReNewal
A 1345-01 @eliminator, RT Angle Arthrow&
65manufacturers in China registered for this device type
39catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Record published | 2016-10-14 |
| Record revised | 2023-05-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 1.4 to 22 mm; angle 45 to 90 °; length 37 cm; length 75 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UMA134501RH | Outer Diameter 4 mm | In distribution |
| UMAR9703A60RH | Outer Diameter 3 mm | In distribution |
| UMA405001RH | Outer Diameter 1.4 mm | In distribution |
| UM225304RH | Outer Diameter 3.5 mm | In distribution |
| REP120824 | Outer Diameter 5.5 mm | In distribution |
| UM7209655RH | Outer Diameter 4 mm | In distribution |
| UME587001RH | Outer Diameter 5.5 mm | In distribution |
| UM7209683RH | Outer Diameter 3 mm | In distribution |
| UMAR9606H45RH | Angle 45 ° | In distribution |
| UM225324RH | Outer Diameter 3.5 mm | In distribution |
| UMAS253001RH | Outer Diameter 4 mm | In distribution |
| UMA353001RH | Outer Diameter 3 mm | In distribution |
| UM7209633R | Outer Diameter 4 mm | In distribution |
| UMA133601RH | Outer Diameter 4 mm | In distribution |
| UMA272301RH | Outer Diameter 2.3 mm | In distribution |
| UMAS373001RH | Outer Diameter 4 mm | In distribution |
| UM7209631RH | Outer Diameter 1.5 mm | In distribution |
| UMA173001RH | Outer Diameter 4 mm | In distribution |
| UM278500350RH | Outer Diameter 3.5 mm | In distribution |
| REP102583C | Outer Diameter 5.5 mm | In distribution |
| UMAR9602M90RH | Angle 90 ° | In distribution |
| UMAR9704A90RH | Outer Diameter 4 mm | In distribution |
| UM7209658RH | Outer Diameter 3 mm | In distribution |
| MSREP115781 | Outer Diameter 5.5 mm | In distribution |
| UMA253001RH | Outer Diameter 3 mm | In distribution |
| UMEIC587001RH | Outer Diameter 5.5 mm | In distribution |
| UMAS133501RH | Outer Diameter 3.5 mm | In distribution |
| MSREP115774 | Outer Diameter 5.5 mm | In distribution |
| REP116167 | Length 37 cm | In distribution |
| UMAR9601SJ4RH | Angle 45 ° | In distribution |
| UMAR9601SJ9RH | Angle 90 ° | In distribution |
| UM8322ARH | Length 75 mm | In distribution |
| UMAR9703A90RH | Outer Diameter 3 mm | In distribution |
| UMEIC687001RH | Outer Diameter 5.5 mm | In distribution |
| UMA183001RH | Outer Diameter 3 mm | In distribution |
| UM101021100R | Outer Diameter 22 mm | In distribution |
| REP104845C | Outer Diameter 5.5 mm | In distribution |
| UM225202RH | Outer Diameter 2.3 mm | In distribution |
| UM7209646R | Outer Diameter 4 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212093 | 2022-01-14 |
| K210526 | 2021-03-12 |
| K190643 | 2019-05-06 |
| K182812 | 2018-12-12 |
| K173889 | 2018-04-09 |
| K122949 | 2013-10-16 |
| K932654 | 1994-02-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-05 | Class II | Under Investigation by firm | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. | 738 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.