Accurian
Introdcr AI0009 100MM 7MM-2MM TIP Enhncd
65manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| 510(k) | K181864 |
| Record published | 2019-04-04 |
| Record revised | 2023-05-03 (version 3) |
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 |
| Storage | Special storage condition: Store between -20°C and 50°C |
| Sizes | Needle gauge 16 to 22 G; length 50 to 150 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AC0008 | Needle Gauge 20.0 G | 10 | In distribution |
| AC0018 | Needle Gauge 22.0 G | 10 | In distribution |
| AC0017 | Needle Gauge 22.0 G | 10 | In distribution |
| AI0005 | Length 100.0 mm | 10 | In distribution |
| AI0006 | Length 150.0 mm | 10 | In distribution |
| AC0005 | Length 100.0 mm | 10 | In distribution |
| AC0007 | Needle Gauge 18.0 G | 10 | In distribution |
| AC0016 | Needle Gauge 22.0 G | 10 | In distribution |
| AC0012 | Length 150.0 mm | 10 | In distribution |
| AC0015 | Length 50.0 mm | 10 | In distribution |
| AC0014 | Needle Gauge 20.0 G | 10 | In distribution |
| AC0002 | Length 100.0 mm | 10 | In distribution |
| AC0003 | Needle Gauge 16.0 G | 10 | In distribution |
| AC0019 | Length 100.0 mm | 10 | In distribution |
| AC0011 | Needle Gauge 20.0 G | 10 | In distribution |
| AI0004 | Needle Gauge 17.0 G | 10 | In distribution |
| AC0010 | Length 100.0 mm | 10 | In distribution |
| AC0020 | Needle Gauge 22.0 G | 10 | In distribution |
| AI0003 | Needle Gauge 17.0 G | 10 | In distribution |
| AC0013 | Length 150.0 mm | 10 | In distribution |
| AC0004 | Needle Gauge 18.0 G | 10 | In distribution |
| AC0001 | Needle Gauge 16.0 G | 10 | In distribution |
| AC0006 | Length 100.0 mm | 10 | In distribution |
| AI0002 | Length 100.0 mm | 10 | In distribution |
| AI0007 | 10 | In distribution | |
| AI0001 | Needle Gauge 17.0 G | 10 | In distribution |
| AI0009 | 10 | In distribution | |
| AC0009 | Needle Gauge 20.0 G | 10 | 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 |
|---|---|
| K061635 | 2006-09-05 |
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.