FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780198123
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
380276
Catalog number
380-276
Device description
"Integra® Jarit® Andrew Mastoid Gouge, 6"", 8mm 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
KAQGOUGE, NASAL, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAQGouge, Nasal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780198123PrimaryGS10
M2743802761SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019812310381780198123

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. 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 made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). 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
00190776422097MillenniumAvalign Technologies, Inc.KAQ2026-07-24
00192896123007Alexander Mastoid GougeSONTEC INSTRUMENTS, INC.KAQ2026-03-31
00757770498956Bausch + LombBausch & Lomb IncorporatedKAQ2025-08-01
00190776392642MillenniumAvalign Technologies, Inc.KAQ2025-05-02
G586E3871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871840Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871850Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871860Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412490Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871760Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
00842962147665HNM MEDICALHNM STAINLESS, LLC.KAQ2023-04-07
00190776362232MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362249MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362256MillenniumAvalign Technologies, Inc.KAQ2023-02-22
M6335143910JEDMEDJEDMED INSTRUMENT COMPANYKAQ2023-02-03
00190776295189MillenniumAvalign Technologies, Inc.KAQ2022-12-12