Synergetics

Stiff 25ga Tano Diamond Dusted Membrane Scraper (DDMS™)

Registry build 21.09.26
6manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code GZX
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Zumax Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Huaian Wolfram Surgical Instruments Huaian Jiangsu Manufacturer 14
Hotry Co., Ltd. Beijing Beijing Manufacturer 9

Record

Regulatory record for Synergetics
Listed by Synergetics USA, Inc.
FDA product code GZX
Device type Instrument, Microsurgical
Device class Class 1
Regulation 21 CFR 882.4525
Premarket notification Exempt
Record published 2016-07-06
Record revised 2018-03-29 (version 2)

Specifications

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, manufacturing date, serial number
Storage Storage environment temperature 59 to 77 °F
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Synergetics
Catalogue number Size Per pack Status
20.04.23 5 In distribution
20.04.25S 5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 759
Ambler Surgical Ambler Surgical, LLC 456
Spetzler MacroVac® PMT Corp. 405
Boss Instruments Boss Instruments, Ltd. 311
Dissector KLS-Martin L.P. 281
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 229
Macrovac® PMT Corp. 190
Avalign Avalign Technologies, Inc. 186
Millennium Avalign Technologies, Inc. 173
Integra® Jarit® Integra LifeSciences Production Corporation 170
Wexler Surgical, Inc. Wexler Surgical, Inc. 168
V. Mueller Steris Corporation 156

Showing 12 of 114. All products under Instrument, Microsurgical

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