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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776420321MillenniumAvalign Technologies, Inc.EYR2026-08-25
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