FDA.reportPublic FDA data

Shukla Winquist 3 - MKS1017

Primary DI
B756MIWC0
Brand
Shukla Winquist 3 - MKS1017
Company
Shukla Medical
Model
MIWC
Device description
Bone Chisel
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZOChisel, Surgical, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B756MIWC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1-727-626-2770CS@ShuklaMedical.com

Regulatory Flags#

DUNS number
159009294
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B756STP071010Shukla Universal Modular Vise Grip SystemSTP071-012026-05-18
B756STP071020Shukla Universal Modular Vise Grip SystemSTP071-022026-05-18
B756STP072010Shukla Universal Modular Vise Grip SystemSTP072-012026-05-18
B756STP072020Shukla Universal Modular Vise Grip SystemSTP072-022026-05-18
B756STP073010Shukla Universal Modular Vise Grip SystemSTP073-022026-05-18
B756STP073020Shukla Universal Modular Vise Grip SystemSTP073-022026-05-18
B756STP0740Shukla Universal Modular Vise Grip SystemSTP0742026-05-18
B756STP0750Shukla Universal Modular Vise Grip SystemSTP0752026-05-18
B756STP0760Shukla Universal Modular Vise Grip SystemSTP0762026-05-18
B756STP0770Shukla Universal Modular Vise Grip SystemSTP0772026-05-18
B756STP0780Shukla Universal Modular Vise Grip SystemSTP0782026-05-18
B756STP0820Shukla Universal Modular Vise Grip SystemSTP0822026-05-18
B756STP0830Shukla Universal Modular Vise Grip SystemSTP0832026-05-18
B756STP0840Shukla Universal Modular Vise Grip SystemSTP0842026-05-18
B756STP0850Shukla Universal Modular Vise Grip SystemSTP0852026-05-18
B756STP0860Shukla Universal Modular Vise Grip SystemSTP0862026-05-18
B756STP159020Shukla Universal Modular Vise Grip SystemSTP159-022026-05-18
B756SHN0550Shukla Universal Modular Vise Grip SystemSHN0552026-04-01
B756STP070010Shukla Universal Modular Vise Grip SystemSTP070-012026-04-01
B756SXT095020Shukla Universal Modular Vise Grip SystemSXT095-022026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373887697BENCOX Surgical InstrumentsCorentec Co., LtdFZO2026-04-10
10649111080036Sklar®SKLAR CORPORATIONFZO2019-02-25
10649111010613Sklar®SKLAR CORPORATIONFZO2019-02-12
10649111052699Sklar®SKLAR CORPORATIONFZO2018-11-26
10381780495215Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780495314Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780509325Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-23
10649111066283Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111066733Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067198Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067556Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067938Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111068317Sklar®SKLAR CORPORATIONFZO2018-10-22
10381780506874Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-17
10649111095245Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095443Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095559Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095825Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096013Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096112Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096341Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096556Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096679Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096822Sklar®SKLAR CORPORATIONFZO2018-09-27
10603295084020SIGMADEPUY (IRELAND)FZO2018-09-24
10603295107798NADEPUY ORTHOPAEDICS, INC.FZO2018-09-24
10603295122715NADEPUY (IRELAND)FZO2018-09-24
10381780499176Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499183Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499190Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18