SharkCut

Shaver Blade_OD 4.2 WL 128 Bevel Edge Cutter Smith&Nephew Type

Registry build 21.09.26
25manufacturers in China registered for this device type
106catalogue 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 SharkCut
Listed by Techcord Co., Ltd., South Korea
FDA product code GFA
Device type Blade, Saw, General & Plastic Surgery, Surgical
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Manufacturer
Premarket notification Exempt
Record published 2024-04-15

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 5
Sizes Outer diameter 3 to 5.5 mm; length 128 to 295 mm

Catalogue Numbers

Catalogue numbers for SharkCut
Catalogue number Size Status
OB1650 Outer Diameter 5.0 mm In distribution
T3655 Outer Diameter 5.5 mm In distribution
T2650 Outer Diameter 5.0 mm In distribution
TSL2850D Outer Diameter 5.0 mm In distribution
T3730 Outer Diameter 3.0 mm In distribution
RB2640 Outer Diameter 4.0 mm In distribution
T2830 Outer Diameter 3.0 mm In distribution
T2635 Outer Diameter 3.5 mm In distribution
OB1840 Outer Diameter 4.0 mm In distribution
RB2840 Outer Diameter 4.0 mm In distribution
T3635 Outer Diameter 3.5 mm In distribution
TSN2850D Outer Diameter 5.0 mm In distribution
TSS2840D Outer Diameter 4.0 mm In distribution
RB2750 Outer Diameter 5.0 mm In distribution
T1742 Outer Diameter 4.2 mm In distribution
TSS3530D Outer Diameter 3.0 mm In distribution
T2842 Outer Diameter 4.2 mm In distribution
OB1940 Outer Diameter 4.0 mm In distribution
T1935 Outer Diameter 3.5 mm In distribution
T2942 Outer Diameter 4.2 mm In distribution
RB2940 Outer Diameter 4.0 mm In distribution
T1955 Outer Diameter 5.5 mm In distribution
T1835 Outer Diameter 3.5 mm In distribution
T3755 Outer Diameter 5.5 mm In distribution
RB2850 Outer Diameter 5.0 mm In distribution
T3750 Outer Diameter 5.0 mm In distribution
TSS2830C Outer Diameter 3.0 mm In distribution
RB2740 Outer Diameter 4.0 mm In distribution
RB2730 Outer Diameter 3.0 mm In distribution
RB2650 Outer Diameter 5.0 mm In distribution
T1855 Outer Diameter 5.5 mm In distribution
T1730 Outer Diameter 3.0 mm In distribution
TSL2830C Outer Diameter 3.0 mm In distribution
T3842 Outer Diameter 4.2 mm In distribution
TSS2850D Outer Diameter 5.0 mm In distribution
T2742 Outer Diameter 4.2 mm In distribution
T3642 Outer Diameter 4.2 mm In distribution
TSN3530D Outer Diameter 3.0 mm In distribution
TSL3530C Outer Diameter 3.0 mm In distribution
T3942 Outer Diameter 4.2 mm In distribution
T1642 Outer Diameter 4.2 mm In distribution
T1750 Outer Diameter 5.0 mm In distribution
TSN2840C Outer Diameter 4.0 mm In distribution
T2935 Outer Diameter 3.5 mm In distribution
T2750 Outer Diameter 5.0 mm In distribution
T2850 Outer Diameter 5.0 mm In distribution
T2930 Outer Diameter 3.0 mm In distribution
T1630 Outer Diameter 3.0 mm In distribution
T3930 Outer Diameter 3.0 mm In distribution
T2855 Outer Diameter 5.5 mm In distribution
T3855 Outer Diameter 5.5 mm In distribution
TSL2840C Outer Diameter 4.0 mm In distribution
T1842 Outer Diameter 4.2 mm In distribution
T3650 Outer Diameter 5.0 mm In distribution
T3830 Outer Diameter 3.0 mm In distribution
TSL2850C Outer Diameter 5.0 mm In distribution
T3742 Outer Diameter 4.2 mm In distribution
T2755 Outer Diameter 5.5 mm In distribution
T2730 Outer Diameter 3.0 mm In distribution
TSS2850C Outer Diameter 5.0 mm In distribution
T2642 Outer Diameter 4.2 mm In distribution
OB1850 Outer Diameter 5.0 mm In distribution
TSL2840D Outer Diameter 4.0 mm In distribution
TSS3530C Outer Diameter 3.0 mm In distribution
TSS2830D Outer Diameter 3.0 mm In distribution
TSS1940D Outer Diameter 4.0 mm In distribution
T2950 Outer Diameter 5.0 mm In distribution
T1850 Outer Diameter 5.0 mm In distribution
TSN1940D Outer Diameter 4.0 mm In distribution
T3950 Outer Diameter 5.0 mm In distribution
OB1640 Outer Diameter 4.0 mm In distribution
TSS2840C Outer Diameter 4.0 mm In distribution
T1830 Outer Diameter 3.0 mm In distribution
T3735 Outer Diameter 3.5 mm In distribution
T3835 Outer Diameter 3.5 mm In distribution
T1655 Outer Diameter 5.5 mm In distribution
T2735 Outer Diameter 3.5 mm In distribution
TSL1930D Outer Diameter 3.0 mm In distribution
T3630 Outer Diameter 3.0 mm In distribution
T3935 Outer Diameter 3.5 mm In distribution
T1650 Outer Diameter 5.0 mm In distribution
OB1740 Outer Diameter 4.0 mm In distribution
TSL3530D Outer Diameter 3.0 mm In distribution
T2955 Outer Diameter 5.5 mm In distribution
RB2830 Outer Diameter 3.0 mm In distribution
TSN2830C Outer Diameter 3.0 mm In distribution
TSL2830D Outer Diameter 3.0 mm In distribution
T1755 Outer Diameter 5.5 mm In distribution
T3850 Outer Diameter 5.0 mm In distribution
T1635 Outer Diameter 3.5 mm In distribution
TSN2830D Outer Diameter 3.0 mm In distribution
TSN3530C Outer Diameter 3.0 mm In distribution
T2655 Outer Diameter 5.5 mm In distribution
RB2950 Outer Diameter 5.0 mm In distribution
TSN2850C Outer Diameter 5.0 mm In distribution
TSN2840D Outer Diameter 4.0 mm In distribution
T1950 Outer Diameter 5.0 mm In distribution
TSL1940D Outer Diameter 4.0 mm In distribution
T1930 Outer Diameter 3.0 mm In distribution
T1735 Outer Diameter 3.5 mm In distribution
TSS1930D Outer Diameter 3.0 mm In distribution
T2630 Outer Diameter 3.0 mm In distribution
T1942 Outer Diameter 4.2 mm In distribution
T3955 Outer Diameter 5.5 mm In distribution
T2835 Outer Diameter 3.5 mm In distribution
TSN1930D Outer Diameter 3.0 mm In distribution

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
Brasseler USA Peter Brasseler Holdings, LLC 438
Blade, Saw, General & Plastic Surgery, Surgical Stryker GmbH 430
Arthrex® Arthrex, Inc. 213
MicroAire Provision 175
Conmed/Linvatec Provision 175

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