FDA.reportPublic FDA data

Modified Javid Clamps

Primary DI
B033KS50020
Brand
Modified Javid Clamps
Company
Kapp Surgical Instrument Co.
Model
KS-5002
Catalog number
KS-5002
Device description
Mod. Javid - .210 tip 6 1/4” Long
Published
2023-06-14
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
HCEClamp, Carotid Artery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCEClamp, Carotid ArteryNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B033KS50020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B033KS50010Modified Javid ClampsKapp Surgical Instrument Co.HCE2023-06-14
B033KS50030Modified Javid ClampsKapp Surgical Instrument Co.HCE2023-06-14
B033KS50040Modified Javid ClampsKapp Surgical Instrument Co.HCE2023-06-14
B033KS50050Modified Javid ClampsKapp Surgical Instrument Co.HCE2023-06-14