FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780191025
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
305501
Catalog number
305-501
Device description
"Integra® Jarit® Rumel Tourniquet, 8-1/4"", Pediatric"
Published
2018-03-02
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
EYRTOURNIQUET, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYRTourniquet, Gastro-UrologyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780191025PrimaryGS10
M2743055011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019102510381780191025

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, reusableA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. 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
+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
00887482043622Symmetry RumelASPEN SURGICAL PRODUCTS, INC.EYR2024-08-12
00887482083857Symmetry RumelASPEN SURGICAL PRODUCTS, INC.EYR2024-08-12
00190776290498MILLENNIUMAvalign Technologies, Inc.EYR2023-09-28
00190776334734MILLENNIUMAvalign Technologies, Inc.EYR2023-09-28
00190776370060MILLENNIUMAvalign Technologies, Inc.EYR2023-09-28
14026704795670PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
14026704795694PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
54026704795678PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
14026704795700PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
14026704795687PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
54026704795692PILLINGTELEFLEX INCORPORATEDEYR2022-12-08
00190776055837AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055844AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055868AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055875AvalignAvalign Technologies, Inc.EYR2021-11-03
00190776055882AvalignAvalign Technologies, Inc.EYR2021-11-03
00190660111786Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111793Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111809Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111816Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111823Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111830Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111847Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
00190660111854Ambler SurgicalAMBLER SURGICAL CORP.EYR2021-01-07
10381780191018Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
10381780457862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
10381780457879Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
M2743055001Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
M2743055011Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02
M2743054981Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEYR2018-03-02