FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780403340
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X20871
Catalog number
X20871
Device description
"Integra® Jarit® Alexander Mastoid Chisel, 7"", 14mm Wide"
Published
2018-05-03
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
10381780403340PrimaryGS10
M274X208711SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178040334010381780403340

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
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

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
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
M274X208711Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03