FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780457862
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
305498
Catalog number
305-498
Device description
"Integra® Jarit® Rumel Obturator (Crochet Hook), 11"", Adult"
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
10381780457862PrimaryGS10
M2743054981SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178045786210381780457862

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Inch

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
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

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
10381780191025Integra® 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