Mini Precise

Mini Precise Axial Needle Holder 3.5mm Right Curved Jaw

Registry build 21.09.26
65manufacturers in China registered for this device type
51catalogue numbers in this listing
2510(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.

Chinese manufacturers registered for FDA product code GEI
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

Regulatory record for Mini Precise
Listed by National Advanced Endoscopy Devices, Inc., United States
FDA product code GEI
Device type Electrosurgical, Cutting & Coagulation & Accessories
Device class Class 2
Regulation 21 CFR 878.4400
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Record published 2017-01-09
Record revised 2019-08-21 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, serial number
Distribution end date 2018-12-20

Catalogue Numbers

Catalogue numbers for Mini Precise
Catalogue number Size Status
xp1619 In distribution
xp1303-R In distribution
xp1461 In distribution
xs1356 In distribution
xp1461-26 In distribution
xp1323-R In distribution
xpw1352-26 In distribution
xp8538 In distribution
xp1460 In distribution
5735B In distribution
xp1318-26 In distribution
xp1354-R In distribution
xp1002 In distribution
xp1375 In distribution
xp1110-26 In distribution
xp1413 In distribution
xp1175-26 In distribution
xpw1353 In distribution
xp1460-26 In distribution
xp1175-35 In distribution
xp1375-R In distribution
xp1323-26-R In distribution
xp1323-26 In distribution
xp1235 In distribution
xp1670-26 In distribution
xp8538-26 In distribution
xp1318 In distribution
xp1303 In distribution
xp1170 In distribution
xp1380-26-R In distribution
xp1413-26 In distribution
xp1185 In distribution
xpw1594 In distribution
xpw1593 In distribution
xp1318-R In distribution
xp1302 In distribution
xp1380 In distribution
xp1413-R In distribution
xp1323 In distribution
xp1670 In distribution
xp1380-R In distribution
xp1302-R In distribution
xp1354-26-R In distribution
xp1630 In distribution
xp1303-26-R In distribution
5735A In distribution
xp1110 In distribution
xp1175 In distribution
xp1354 In distribution
xpw1352 Withdrawn
xpw1354 Withdrawn

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K081553 2008-09-29
K081503 2008-09-25

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer