FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780129813
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
440344
Catalog number
440-344
Device description
"Integra® Jarit® Hajek-Koffler Punch, 5-1/2"", Angled Up 45°, 4mm Bite"
Published
2016-08-11
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
KTFPUNCH, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTFPunch, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780129813PrimaryGS10
M2744403441SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012981310381780129813

GMDN Terms#

Term, Definition table
TermDefinition
ENT soft-tissue cutting forcepsA hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree
Catheter Gauge45French
Device Size Text, specify0
Width4Millimeter

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
04054462900404evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905829evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905843evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905850evonosevonos GmbH & Co. KGKTF2026-08-18
04054462908912evonosevonos GmbH & Co. KGKTF2026-08-18
04054462915163evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915170evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915187evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915194evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915200evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915217evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915224evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915231evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915248evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915255evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915262evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915279evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915286evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915293evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915309evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915316evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915323evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915347evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915354evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915361evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915378evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915385evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915392evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915408evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915415evonosevonos GmbH & Co. KGKTF2026-08-17