FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2743853821
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
385-382
Catalog number
385382
Device description
House Tympanoplasty Knife, 6-1/2", Curved
Published
2018-03-22
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
JYOKNIFE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780391159PrimaryGS10
M2743853821SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178039115910381780391159

GMDN Terms#

Term, Definition table
TermDefinition
Tympanotomy knife, reusableA hand-held manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife, it is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharply-pointed cutting blade of various shapes at the distal end. 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
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11
10381780154501Integra® Ruggles®-Redmond™R2382R23822016-08-11
10381780154518Integra® Ruggles®-Redmond™R2384R23842016-08-11
10381780154525Integra® Ruggles®-Redmond™R2389R23892016-08-11
10381780154532Integra® Ruggles®-Redmond™R2396R23962016-08-11
10381780154549Integra® Ruggles®-Redmond™R2397R23972016-08-11
10381780154556Integra® Ruggles®-Redmond™R2398R23982016-08-11
10381780154563Integra® Ruggles®-Redmond™R2399R23992016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462901937evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906390evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906406evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906413evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906420evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906437evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906444evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906451evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906468evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906475evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906536evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906543evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906581evonosevonos GmbH & Co. KGJYO2026-08-21
04054462906598evonosevonos GmbH & Co. KGJYO2026-08-21
04054462900282evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901913evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901920evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901951evonosevonos GmbH & Co. KGJYO2026-08-18
04054462901968evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906482evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906499evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906550evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906567evonosevonos GmbH & Co. KGJYO2026-08-18
04054462906574evonosevonos GmbH & Co. KGJYO2026-08-18
04054462907533evonosevonos GmbH & Co. KGJYO2026-08-18
09348811109194INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811150257INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-31
09348811109798INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-07-30
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11