Neptune
SafeAir Smoke Evacuation Pencil, Push Button, Non-Coated, Split Tubing, Non-Sterile
65manufacturers in China registered for this device type
24catalogue numbers in this listing
9510(k) clearances naming this product code
4recalls 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-12-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -20 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 75 % RH |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0703165201 | In distribution | |
| 0703006125 | In distribution | |
| 0703070201 | In distribution | |
| 0703165200 | In distribution | |
| 0703070202 | In distribution | |
| 0703-070-200 | In distribution | |
| 0703246002 | In distribution | |
| 0703146002 | In distribution | |
| 0703125201 | In distribution | |
| 0703-125-202 | In distribution | |
| 0703146003 | In distribution | |
| 0703146000 | In distribution | |
| 0703146001 | In distribution | |
| 0703246000 | In distribution | |
| 0703246003 | In distribution | |
| 0703006070 | In distribution | |
| 0703165202 | In distribution | |
| 0703006165 | In distribution | |
| 0703007270 | In distribution | |
| 0703070203 | In distribution | |
| 0703147000 | In distribution | |
| 0703147001 | In distribution | |
| 0703125200 | In distribution | |
| 0703246001 | 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 |
|---|---|
| K221074 | 2022-09-16 |
| K171391 | 2018-01-26 |
| K160050 | 2016-05-03 |
| K160693 | 2016-04-13 |
| K153679 | 2016-01-22 |
| K063480 | 2007-05-22 |
| K061225 | 2006-09-14 |
| K033232 | 2004-02-25 |
| K861742 | 1986-07-23 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2020-03-26 | Class II | Under Investigation by firm | Due to a distribution error, product from the affected lot was shipped expired. | 40 units | 2020-07-15 |
| 2020-01-13 | Class II | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. | 15150 | 2021-08-10 |
| 2020-01-13 | Class II | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. | 15150 | 2021-08-10 |
| 2020-01-13 | Class II | Under Investigation by firm | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. | 15150 | 2021-08-10 |
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.