FDA.reportPublic FDA data

Coned Heparin Needles

Primary DI
B033KS400740
Brand
Coned Heparin Needles
Company
Kapp Surgical Instrument Co.
Model
KS-4007-4
Catalog number
KS-4007-4
Device description
Coned Heparin Needles – Size 0 - 4in
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
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B033KS400740PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular irrigation cannula, peripheralA sterile, rigid tube designed to be surgically inserted, temporarily, into a peripheral blood vessel to function as a channel for the transport of irrigation fluid (e.g., saline, heparin solution) during open vascular surgery. It is typically made of metal with a shaped/bulbous tip (e.g., cone-, olive-shaped) and may be intended to be bent into shape; as it is a rigid device it is not intended to be advanced more than a minimal distance within the lumen of the blood vessel. This is a single-use 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
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
B033KS400770Coned Heparin NeedlesKS-4007-7KS-4007-72023-06-14
B033KS40080Coned Heparin NeedlesKS-4008KS-40082023-06-14
B033KS50010Modified Javid ClampsKS-5001KS-50012023-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403249MillenniumAvalign Technologies, Inc.GEA2026-07-19
00810220800485Adler Instrument CompanyAdler, Inc.GEA2026-07-17
10810128462782StayPort™ Cannula 5 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
B382SD2303290Surgical DirectSurgical Direct, Inc.GEA2026-07-14
B382SD303490Surgical DirectSurgical Direct, Inc.GEA2026-07-14
00810130456574Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456581Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456598Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456604Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456611Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
20192253036821MonojectCardinal Health 200, LLCGEA2026-07-09
00850083275709Intrace USAPILOTIS TECH LLCGEA2026-07-03
00810130456550Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00810130456567Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00840329838232BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
G4533312250PEAK MEDICALPeak Medical Distribution Inc.GEA2026-06-08
00810130456420Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456437Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456444Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456451Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456468Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456475Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05