PMI
PMI PTFE Coated Laparoscopic Thin Curved Spatula Split 33cm
65manufacturers in China registered for this device type
68catalogue numbers in this listing
17recalls on this 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 | Progressive Medical Technology, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Record published | 2016-09-23 |
| Record revised | 2019-02-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 6, box of 12, box of 5, box of 10, pack of 12, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P0430 | In distribution | |
| P0028 | In distribution | |
| P0460 | In distribution | |
| P0013M | In distribution | |
| PMIIN120 | In distribution | |
| P0012M | In distribution | |
| P0012A | In distribution | |
| P0016A | In distribution | |
| P0021X | In distribution | |
| P0118A | In distribution | |
| P0440 | In distribution | |
| P0014A | In distribution | |
| P0017S | In distribution | |
| P0036H | In distribution | |
| P0020SX | In distribution | |
| P0113M | In distribution | |
| P0013 | In distribution | |
| P0015 | In distribution | |
| P0480 | In distribution | |
| P0021S | In distribution | |
| P1650 | In distribution | |
| P0014M | In distribution | |
| P0105S | In distribution | |
| P0019S | In distribution | |
| P0014 | In distribution | |
| P0018S | In distribution | |
| P0012AM | In distribution | |
| P1652 | In distribution | |
| P0490 | In distribution | |
| P1652 | In distribution | |
| P1653 | In distribution | |
| P0410 | In distribution | |
| P0450 | In distribution | |
| P0027 | In distribution | |
| P0100S | In distribution | |
| P0020S | In distribution | |
| PMIIN150 | In distribution | |
| P0420 | In distribution | |
| P0021SX | In distribution | |
| P0017 | In distribution | |
| P0019 | In distribution | |
| P0016M | In distribution | |
| P0016 | In distribution | |
| P0026S | In distribution | |
| P0100X | In distribution | |
| P0105 | In distribution | |
| P1651 | In distribution | |
| P0470 | In distribution | |
| P0035H | In distribution | |
| P4500 | In distribution | |
| P0020 | In distribution | |
| P0021 | In distribution | |
| P0027S | In distribution | |
| P0026 | In distribution | |
| P0022 | In distribution | |
| P0018 | In distribution | |
| P0014AM | In distribution | |
| P0016AM | In distribution | |
| P0020X | In distribution | |
| P0024S | In distribution | |
| P0028M | In distribution | |
| P0022S | In distribution | |
| P0012 | In distribution | |
| P0113 | In distribution | |
| P0024 | In distribution | |
| P0100 | In distribution | |
| P0009 | In distribution | |
| P0118 | 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
Recalls
17 of these are 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 |
|---|---|---|---|---|---|
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 173 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 16 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 20 boxes with 12 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 60 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 11 boxes with 25 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 59 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 28 boxes with 12 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 20 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 19 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 39 boxes with 12 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 19 boxes with 12 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 18 boxes with 12 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 4 boxes containing 6 individually packaged pieces each | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 20 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 38 boxes with 6 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 150 boxes with 12 units each. | 2014-05-07 |
| 2013-04-12 | Class II | Manufacturing material removal | Product coatings require 510K approval. | 27 boxes with 12 units each. | 2014-05-07 |
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.