Brasseler USA

KM5100-37-116 13.0 X 6.5MM Rasp

Registry build 21.09.26
25manufacturers in China registered for this device type
438catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (7), Guangdong (7), Shanghai (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GFA
Manufacturer City Province Registered as Device types
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Dongguan Miqiang Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Zhejiang Longyou Landmedical Technology Co., Ltd. Longyou Zhejiang Contract manufacturer 7
Ningbo Advan Electrical Co., Ltd. Cixi Zhejiang Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62

Showing 12 of 25. All 25 manufacturers in China registered for Blade, Saw, General & Plastic Surgery, Surgical

Record

Regulatory record for Brasseler USA
Listed by Peter Brasseler Holdings, LLC
FDA product code GFA
Device type Blade, Saw, General & Plastic Surgery, Surgical
Device class Class 1
Regulation 21 CFR 878.4820
Premarket notification Exempt
Record published 2024-06-11
Record revised 2026-01-13 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Brasseler USA
Catalogue number Size Status
AR1-25-100-127-SAG 5P In distribution
5022963M0 In distribution
5003974M0 In distribution
5023849M0 In distribution
AR1-21-90-127-SAG 5P In distribution
5025101M0 In distribution
5028460M0 In distribution
5022743M0 In distribution
5009206M0 In distribution
5023004M0 In distribution
5023737M0 In distribution
5028561M0 In distribution
5022967M0 In distribution
5023059M0 In distribution
5003693M0 In distribution
AR1-25-70-094-SAG 5P In distribution
5004013M0 In distribution
5023848M0 In distribution
5004007M0 In distribution
5022970M0 In distribution
5022923M0 In distribution
5022819M0 In distribution
5022756M0 In distribution
10-110 In distribution
5022922M0 In distribution
5022823M0 In distribution
5011686M0 In distribution
AR1-21-90-127-SAG In distribution
AR1-11-775-160-RCP In distribution
5010168M0 In distribution
5020325M0 In distribution
5028409M0 In distribution
5028461M0 In distribution
BML-S90016NS In distribution
AR1-125-90-119-SAG 5P In distribution
5004004M0 In distribution
5003703M0 In distribution
5023735M0 In distribution
AR1-25-90-119-SAG In distribution
5023011M0 In distribution
5022915M0 In distribution
5028410M0 In distribution
5003719M0 In distribution
5022759M0 In distribution
5010167M0 In distribution
5003961M0 In distribution
AR1-9-30-079-SAG In distribution
5025446M0 In distribution
5022920M0 In distribution
5011255M0 In distribution
AR1-125-70-094-RCP In distribution
5004009M0 In distribution
AR1-25-90-099-SAG 5P In distribution
5028413M0 In distribution
5003993M0 In distribution
AR1-19-90-137-SAG 5P In distribution
5003725M0 In distribution
5022677M0 In distribution
5003979M0 In distribution
5003994M0 In distribution
5003960M0 In distribution
5010165M0 In distribution
AR1-63-60-104-RCP In distribution
5029429M0 In distribution
AR1-25-75-127-SAG In distribution
5008269M0 In distribution
5025840M0 In distribution
5004019M0 In distribution
AR1-19-90-119-SAG In distribution
5029427M0 In distribution
5004014M0 In distribution
5022878M0 In distribution
5003726M0 In distribution
5022913M0 In distribution
AR1-125-90-127-SAG 5P In distribution
5022968M0 In distribution
5024349M0 In distribution
5029431M0 In distribution
5010308M0 In distribution
5003755M0 In distribution
5009198M0 In distribution
5022761M0 In distribution
5022758M0 In distribution
10-112 In distribution
5003826M0 In distribution
5007058M0 In distribution
AR1-345-60-079-SAG 5P In distribution
5022753M0 In distribution
5003962M0 In distribution
5009226M0 In distribution
5008264M0 In distribution
5028459M0 In distribution
5029426M0 In distribution
AR1-19-90-127-SAG 5P In distribution
5026409M0 In distribution
AR1-25-90-147-SAG 5P In distribution
5020326M0 In distribution
AR1-9-30-079-SAG 5P In distribution
5010173M0 In distribution
AR1-25-90-127-SAG 5P In distribution
AR1-21-90-119-SAG In distribution
5003711M0 In distribution
5022874M0 In distribution
5003688M0 In distribution
5022815M0 In distribution
5003743M0 In distribution
AR1-19-100-137-SAG 5P In distribution
5010174M0 In distribution
5003707M0 In distribution
5009229M0 In distribution
AR1-25-70-147-SAG 5P In distribution
AR1-125-90-089-SAG 5P In distribution
BML-S90017NS In distribution
5004021M0 In distribution
AR1-125-708-112-RCP In distribution
5023057M0 In distribution
5023738M0 In distribution
5003991M0 In distribution
5006966M0 In distribution
5004020M0 In distribution
5010171M0 In distribution
5009255M0 In distribution
5003985M0 In distribution
5003673M0 In distribution
10-103 In distribution
5003825M0 In distribution
5023019M0 In distribution
5003570M0 In distribution
5023012M0 In distribution
5022870M0 In distribution
5010166M0 In distribution
5024857M0 In distribution
5011138M0 In distribution
5022918M0 In distribution
5009262M0 In distribution
10-113 In distribution
5009259M0 In distribution
5004010M0 In distribution
5003691M0 In distribution
5025245M0 In distribution
5022816M0 In distribution
5022814M0 In distribution
5023015M0 In distribution
5003829M0 In distribution
5019766M0 In distribution
5009224M0 In distribution
5022745M0 In distribution
5028458M0 In distribution
5003727M0 In distribution
5022917M0 In distribution
5025837M0 In distribution
5022875M0 In distribution
5004000M0 In distribution
5003995M0 In distribution
5025244M0 In distribution
5023001M0 In distribution
5007508M0 In distribution
5003986M0 In distribution
5003998M0 In distribution
5029430M0 In distribution
5023000M0 In distribution
5003997M0 In distribution
5028558M0 In distribution
5029435M0 In distribution
5022971M0 In distribution
5003706M0 In distribution
5003674M0 In distribution
5028556M0 In distribution
5004011M0 In distribution
5022914M0 In distribution
AR1-125-708-112-RCP In distribution
5004025M0 In distribution
5003656M0 In distribution
AR1-11-775-160-RCP In distribution
5011256M0 In distribution
5022759M1 In distribution
5004001M0 In distribution
5003983M0 In distribution
5022749M0 In distribution
10-104 In distribution
5003758M0 In distribution
AR1-35-64-089-SAG In distribution
5025100M0 In distribution
5012111M0 In distribution
5011329M0 In distribution
5009175M0 In distribution
5003709M0 In distribution
AR1-29-55-102-SAG 5P In distribution
5029428M0 In distribution
5003907M0 In distribution
AR1-19-100-119-SAG In distribution
5004022M0 In distribution
AR1-185-70-091-SAG In distribution
5009257M0 In distribution
5022964M0 In distribution
AR1-125-90-089-SAG In distribution
5022755M0 In distribution
10-105 In distribution
5003982M0 In distribution
5022744M0 In distribution
AR1-125-90-127-SAG In distribution
5022876M0 In distribution
AR1-21-90-137-SAG 5P In distribution
5009225M0 In distribution
5003989M0 In distribution
AR1-25-90-127-SAG In distribution
Large Bone Blades In distribution
5009177M0 In distribution
5028554M0 In distribution
5003661M0 In distribution
AR1-125-90-137-SAG In distribution
AR1-25-90-137-SAG 5P In distribution
5007059M0 In distribution
AR1-19-90-137-SAG In distribution
5004015M0 In distribution
5006964M0 In distribution
5003987M0 In distribution
5003574M0 In distribution
AR1-125-90-137-SAG 5P In distribution
5022748M0 In distribution
5023002M0 In distribution
5003996M0 In distribution
5025839M0 In distribution
AR1-19-100-119-SAG 5P In distribution
5029436M0 In distribution
5003705M0 In distribution
5003748M0 In distribution
5003839M0 In distribution
5029432M0 In distribution
5022996M0 In distribution
5003777M0 In distribution
5022760M0 In distribution
5004003M0 In distribution
AR1-21-90-119-SAG 5P In distribution
5003854M0 In distribution
5023010M0 In distribution
5003720M0 In distribution
5022871M0 In distribution
5022873M0 In distribution
5003770M0 In distribution
5003836M0 In distribution
5023058M0 In distribution
5003844M0 In distribution
5003964M0 In distribution
AR1-112-775-117-RCP In distribution
5010176M0 In distribution
AR1-345-60-079-SAG In distribution
5003589M0 In distribution
AR1-125-70-094-RCP In distribution
5022747M0 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imedicom SAW Blade Imedicom Co., Ltd. 1,283
Stablecut® Zimmer Orthopaedic Surgical Products 1,154
Medline Medline Industries, Inc. 999
Blade, Saw, General & Plastic Surgery, Surgical Sterilmed, Inc. 994
Komet Surgical Saw Blade Gebr. Brasseler Gmbh & Co. KG 843
Stryker Provision 613
Blade, Saw, General & Plastic Surgery, Surgical Omega Surgical Instruments, Inc. 490
Blade, Saw, General & Plastic Surgery, Surgical Stryker GmbH 430
Arthrex® Arthrex, Inc. 213
MicroAire Provision 175
Conmed/Linvatec Provision 175
Conmed ConMed Corporation 171

Showing 12 of 488. All products under Blade, Saw, General & Plastic Surgery, Surgical

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