FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2743853051
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
385-305
Catalog number
385305
Device description
House Middle Ear Mirror, 6-3/4", 2mm Diameter, Angled 45°
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
KAIMIRROR, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780390954PrimaryGS10
M2743853051SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178039095410381780390954

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgery mirrorA reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree
Device Size Text, specify0
Outer Diameter2.3Millimeter

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
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462902880evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902910evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902934evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902941evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902958evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902965evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902972evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902989evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902996evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903061evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903078evonosevonos GmbH & Co. KGKAI2026-08-21
04054462903085evonosevonos GmbH & Co. KGKAI2026-08-21
04054462902767evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902774evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902781evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902798evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902804evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902811evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902828evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902835evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902842evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902859evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902866evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902873evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902897evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902903evonosevonos GmbH & Co. KGKAI2026-08-18
04054462902927evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903009evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903016evonosevonos GmbH & Co. KGKAI2026-08-18
04054462903023evonosevonos GmbH & Co. KGKAI2026-08-18