FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780374367
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X3099
Catalog number
X3099
Device description
Integra® Jarit® Dittel Urethal Sound
Published
2017-06-27
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
FBXSOUND, URETHRAL, METAL OR PLASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780374367PrimaryGS10
M274X30991SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178037436710381780374367

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Device Size Text, specify0

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
10381780509356Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-10-23
10381780500025Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500032Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500049Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500056Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500063Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500070Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500087Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500094Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500100Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500117Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500124Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500131Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500148Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500155Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500162Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500179Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500186Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500193Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500209Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500216Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500223Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500230Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500247Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500254Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500261Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500278Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500285Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500292Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18
10381780500308Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFBX2018-09-18