FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780129806
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
440342
Catalog number
440-342
Device description
"Integra® Jarit® Hajek-Koffler Punch, 5-1/2"", Angled Down 90°, 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
10381780129806PrimaryGS10
M2744403421SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012980610381780129806

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
Angle90degree
Catheter Gauge90French
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
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
00190776417871MillenniumAvalign Technologies, Inc.KTF2026-03-11
04250676717351Kerrison rongeurSpiggle & Theis Medizintechnik GmbHKTF2025-09-25
00194613029340MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036331MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036355MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036379MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036386MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036393MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613111533MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613123741MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00190776402624MillenniumAvalign Technologies, Inc.KTF2025-06-24
00190776402433MillenniumAvalign Technologies, Inc.KTF2025-06-23
00192896121614Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2025-06-06
00190776394943MillenniumAvalign Technologies, Inc.KTF2025-05-08
00194613029395MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036324MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036348MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036362MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613082239MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613108045MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00192896120945Ostrum Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-12-10
00190776384913MillenniumAvalign Technologies, Inc.KTF2024-08-26
00192896119000Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00192896119024Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00887482118801Symmetry CarleyASPEN SURGICAL PRODUCTS, INC.KTF2024-08-20
00888515134003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242135BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242142BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242173BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515243507BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28