FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M274X20861
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X2086
Catalog number
X2086
Device description
Rubber Bulb with Tubing for REF# 19-70 (Bruening Otoscope)
Published
2018-08-16
Public version status
Update
Distribution status
Not 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
ERAOTOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780403289PrimaryGS10
M274X20861SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178040328910381780403289

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, endoscopicAn endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. 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
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

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Primary DI, Brand, Company table
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04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
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04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
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16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
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KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
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10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21