FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M274X208651
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X20865
Catalog number
X20865
Device description
Alexander Mastoid Chisel 7", 8mm 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
OTC
false
Sterile
false
Single use
false

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
10381780403319PrimaryGS10
M274X208651SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178040331910381780403319

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
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

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
M274X208671Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208691Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03
M274X208711Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYD2018-05-03