FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780145356
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
310575
Catalog number
310-575
Device description
"Integra® Jarit® Dardik Tunneler, 19-1/2"", 8mm Inside diameter, 10mm outside diameter"
Published
2016-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZYGraft,vascular,stainless steel tunneler

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZYGraft, Vascular, Stainless Steel TunnelerCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780145356PrimaryGS10
M2743105751SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178014535610381780145356

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613745003009KMRtrack Monitoring marker KMR013 (48) GenBioMZY2025-12-26
00884908089783N/AN/AMedical Components, Inc.MZY2019-09-07
50884908089788N/AN/AMedical Components, Inc.MZY2019-09-07
00884908144680N/AMedical Components, Inc.MZY2019-08-28
00884908144697N/AMedical Components, Inc.MZY2019-08-28
00884908144703N/AMedical Components, Inc.MZY2019-08-28
00884908144710N/AMedical Components, Inc.MZY2019-08-28
00884908144727N/AMedical Components, Inc.MZY2019-08-28
00884908144741N/AMedical Components, Inc.MZY2019-08-28
50884908144685N/AMedical Components, Inc.MZY2019-08-28
50884908144692N/AMedical Components, Inc.MZY2019-08-28
50884908144708N/AMedical Components, Inc.MZY2019-08-28
50884908144715N/AMedical Components, Inc.MZY2019-08-28
50884908144722N/AMedical Components, Inc.MZY2019-08-28
50884908144746N/AMedical Components, Inc.MZY2019-08-28
00884908142044TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142051TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142068TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908142075TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142049TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142056TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142063TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
50884908142070TUNNELERTUNNELERMedical Components, Inc.MZY2019-08-17
00884908145656N/AN/AMedical Components, Inc.MZY2019-08-10
00884908145663N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145651N/AN/AMedical Components, Inc.MZY2019-08-10
50884908145668N/AN/AMedical Components, Inc.MZY2019-08-10
00884908039917TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
50884908039912TUNNELERTUNNELERMedical Components, Inc.MZY2017-07-28
00884908031119TUNNELERMedical Components, Inc.MZY2017-05-18