FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780403296
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X20861
Catalog number
X20861
Device description
"Integra® Jarit® Alexander Mastoid Chisel 7"", 4mm 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
10381780403296PrimaryGS10
M274X208611SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178040329610381780403296

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
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

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