FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2744755451
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
475-545
Catalog number
475545
Device description
McCrea Urethral Sound, 7-1/4", 28 French (9.3mm)
Published
2018-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10381780467281PrimaryGS10
M2744755451SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178046728110381780467281

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.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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