FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780216964
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
P4765
Catalog number
P4765
Device description
Integra® Jarit® Cinelli Osteotome, Double Guarded, Straight
Published
2018-03-23
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
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780216964PrimaryGS10
M274P47651SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178021696410381780216964

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width16Millimeter

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
04054462912070evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912094evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912216evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912223evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912254evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912261evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912421evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912520evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912940evonosevonos GmbH & Co. KGGFI2026-08-19
04054462912957evonosevonos GmbH & Co. KGGFI2026-08-19
04054462900305evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900312evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900329evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900336evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900343evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900350evonosevonos GmbH & Co. KGGFI2026-08-18
04054462900367evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912087evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912100evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912131evonosevonos GmbH & Co. KGGFI2026-08-18
04054462912148evonosevonos GmbH & Co. KGGFI2026-08-18
00841435123717TecometTECOMET INC.GFI2026-07-30
00841435123724TecometTECOMET INC.GFI2026-07-30
00841435123731TecometTECOMET INC.GFI2026-07-30
00190776395384MillenniumAvalign Technologies, Inc.GFI2026-07-13
00841435123557TecometTECOMET INC.GFI2025-02-07
00841435123564TecometTECOMET INC.GFI2025-02-07
00841435123571TecometTECOMET INC.GFI2025-02-07
00841435121355TecometTECOMET INC.GFI2023-07-21
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03