FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780197836
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
380175
Catalog number
380-175
Device description
Integra® Jarit® Krause Ear Snare, Includes Package of 12 Snare Wires
Published
2018-03-02
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
JZDSNARE, EAR

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780197836PrimaryGS10
M2743801751SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019783610381780197836

GMDN Terms#

Term, Definition table
TermDefinition
Ear snareA hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

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Primary DI, Brand, Company table
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20757770457667Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
20757770457674Bausch + LombBausch & Lomb IncorporatedJZD2026-04-30
00757770412914Bausch + LombBausch & Lomb IncorporatedJZD2025-08-04
00842962145937HNM MedicalHNM STAINLESS, LLC.JZD2024-03-08
00888515231061BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00888515231085BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JZD2024-02-28
00190776221171AvalignAvalign Technologies, Inc.JZD2023-06-23
00842331189456Novo Surgical Inc. NOVO SURGICAL, INC.JZD2022-11-14
00190660173708Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
00190660173715Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
00190660173722Ambler SurgicalAMBLER SURGICAL CORP.JZD2021-01-04
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