FDA.reportPublic FDA data

Cosgrove Valve Retractor System

Primary DI
B033KS71019
Brand
Cosgrove Valve Retractor System
Company
Kapp Surgical Instrument Co.
Model
KS-7101-9
Catalog number
KS-7101-9
Device description
"Tricuspid Retractor Blade (custom 9"" handle length)"
Published
2022-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B033KS71019PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(216) 587-4400info@kappsurgical.com

Regulatory Flags#

DUNS number
004171112
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B033KS99911PCL RetractorKS-9991KS-99912025-04-15
B033KS9993L1Lateral Tibia Retractor - LeftLeftKS-9993-L2025-04-15
B033KS9993R1Lateral Tibia Retractor - RightRightKS-9993-R2025-04-15
B033KS99941Knee RetractorMedial Knee RetractorKS-99942025-03-26
B033K9536N0Bari RingNitinol Version2017-02-10
B033KS400140Coned Heparin NeedlesKS-4001-4KS-4001-42023-06-14
B033KS400170Coned Heparin NeedlesKS-4001-7KS-4001-72023-06-14
B033KS400240Coned Heparin NeedlesKS-4002-4KS-4002-42023-06-14
B033KS400270Coned Heparin NeedlesKS-4002-7KS-4002-72023-06-14
B033KS400340Coned Heparin NeedlesKS-4003-4KS-4003-42023-06-14
B033KS400370Coned Heparin NeedlesKS-4003-7KS-4003-72023-06-14
B033KS400440Coned Heparin NeedlesKS-4004-4KS-4004-42023-06-14
B033KS400470Coned Heparin NeedlesKS-4004-7KS-4004-72023-06-14
B033KS400540Coned Heparin NeedlesKS-4005-4KS-4005-42023-06-14
B033KS400570Coned Heparin NeedlesKS-4005-7KS-4005-72023-06-14
B033KS400640Coned Heparin NeedlesKS-4006-4KS-4006-42023-06-14
B033KS400670Coned Heparin NeedlesKS-4006-7KS-4006-72023-06-14
B033KS400740Coned Heparin NeedlesKS-4007-4KS-4007-42023-06-14
B033KS400770Coned Heparin NeedlesKS-4007-7KS-4007-72023-06-14
B033KS40080Coned Heparin NeedlesKS-4008KS-40082023-06-14

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