Brasseler USA

TINISOS6 TIN Comp Isos #6HDL 1P

Registry build 21.09.26
110manufacturers in China registered for this device type
45catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (31), Jiangsu (27), Guangdong (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MDM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Dongguan Hong De Medical Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 32
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19

Showing 12 of 110. All 110 manufacturers in China registered for Instrument, Manual, Surgical, General Use

Record

Regulatory record for Brasseler USA
Listed by Peter Brasseler Holdings, LLC
FDA product code MDM
Device type Instrument, Manual, Surgical, General Use
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2022-12-08
Record revised 2023-08-10 (version 2)

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, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Brasseler USA
Catalogue number Size Status
5023261U0 In distribution
5023273U0 In distribution
5023285U0 In distribution
5023260U0 In distribution
5023269U0 In distribution
5023295U0 In distribution
5023300U0 In distribution
5023258U0 In distribution
5023279U0 In distribution
5023281U0 In distribution
5023288U0 In distribution
5023286U0 In distribution
5023282U0 In distribution
5023272U0 In distribution
5023289U0 In distribution
5023292U0 In distribution
5023270U0 In distribution
5023265U0 In distribution
5023278U0 In distribution
5023271U0 In distribution
5023297U0 In distribution
5023268U0 In distribution
5023280U0 In distribution
5023262U0 In distribution
5026522U0 In distribution
5023298U0 In distribution
5023259U0 In distribution
5023266U0 In distribution
5023293U0 In distribution
5023291U0 In distribution
5023299U0 In distribution
5023274U0 In distribution
5023267U0 In distribution
5023277U0 In distribution
5023287U0 In distribution
5023283U0 In distribution
5023264U0 In distribution
5023294U0 In distribution
5026521U0 In distribution
5023276U0 In distribution
5023290U0 In distribution
5023296U0 In distribution
5023284U0 In distribution
5023275U0 In distribution
5023263U0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arthrex® Arthrex, Inc. 1,686
TSI Tedan Surgical Innovations, L.L.C. 1,181
Medfix Medfix International, LLC 514
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 446
Fentex Fentex medical GmbH 407
Millennium Avalign Technologies, Inc. 337
Synergetics Synergetics USA, Inc. 312
American Medicals American Medicals 298
gSource Gsource, LLC. 291
Life Instruments Life Instrument Corp. 274
Ambler Surgical Ambler Surgical, LLC 272
Instrument, Manual, Surgical, General Use Karl Storz GmbH & Co. KG 261

Showing 12 of 1,364. All products under Instrument, Manual, Surgical, General Use

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