FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780182849
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
205313
Catalog number
205-313
Device description
"Integra® Jarit® Balfour Fourth Blade Attachment, for Left Arm, 9-1/2"", for Ref#'s 205-315 and 205-316"
Published
2018-01-31
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
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780182849PrimaryGS10
M2742053131SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178018284910381780182849

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. 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
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
09348811114068INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811114075INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-05-29
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07898506813698QuinelatoSchobell Industrial LtdaFFO2022-12-16
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268550Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23