Scanlan® MicroSurgical Instruments

Scanlan Aneurysm Ruler Curved Blunt 1MM Calibrated TIP 7 1/4" / 18.5CM

Registry build 21.09.26
6manufacturers in China registered for this device type
46catalogue 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 Scanlan® MicroSurgical Instruments
Listed by Scanlan International, Inc., United States
FDA product code GZX
Device type Instrument, Microsurgical
Device class Class 1
Regulation 21 CFR 882.4525
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-02-06
Record revised 2021-04-02 (version 3)

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

Catalogue Numbers

Catalogue numbers for Scanlan® MicroSurgical Instruments
Catalogue number Size Status
3784-13 In distribution
8008-400 In distribution
3784-14 In distribution
3784-47 In distribution
3784-41 In distribution
3784-31 In distribution
3781-18 In distribution
3784-121 In distribution
4004-120 In distribution
3784-11 In distribution
1820-02 In distribution
3784-09 In distribution
8008-234 In distribution
4900-00 In distribution
4900-01 In distribution
9009-146 In distribution
3784-15 In distribution
3781-14 In distribution
8008-430 In distribution
1820-07 In distribution
3784-42 In distribution
8008-232 In distribution
4004-118 In distribution
3784-30 In distribution
3784-02 In distribution
8008-236 In distribution
4004-122 In distribution
3003-800 In distribution
8008-230 In distribution
9009-02 In distribution
3784-33 In distribution
1820-10 In distribution
9009-104 In distribution
9009-106 In distribution
3784-03 In distribution
3784-01 In distribution
8008-432 In distribution
3784-12 In distribution
9009-142 In distribution
9009-100 In distribution
3784-10 In distribution
1001-52 In distribution
1820-05 In distribution
3784-32 In distribution
3784-40 In distribution
9009-144 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