FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780198079
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
380270
Catalog number
380-270
Device description
"Integra® Jarit® Andrew Mastoid Chisel, 5-7/8"", 5mm Wide, Straight"
Published
2018-01-31
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
JYDCHISEL, MASTOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYDChisel, MastoidGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780198079PrimaryGS10
M2743802701SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019807910381780198079

GMDN Terms#

Term, Definition table
TermDefinition
Mastoid chiselA single-bladed, surgical instrument, bevelled on one side with a flat cutting edge that is used to cut and shape the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) during ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically a one-piece instrument made of high-grade stainless steel. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048266149190PediatrOS™ FlexTack™/ RigidTack™Merete GmbHJYD2021-11-01
00190660008499Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008505Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008512Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008529Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008536Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008543Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008604Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008611Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008628Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008635Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008642Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
00190660008659Ambler SurgicalAMBLER SURGICAL CORP.JYD2021-01-04
10381780198086Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
10381780198093Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
10381780198109Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
M2743802711Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
M2743802721Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
M2743802731Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-09-12
10381780403296Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
10381780403302Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
10381780403319Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
10381780403326Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
10381780403333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
10381780403340Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208631Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208651Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208671Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208691Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03