FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780193050
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
P1520
Catalog number
P1520
Device description
"Integra® Jarit® Rozner Nasal Osteotome, 6-1/2"", 6.5mm Wide"
Published
2018-04-02
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
HWMOSTEOTOME

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780193050PrimaryGS10
M274P15201SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019305010381780193050

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
Width6.5Millimeter

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
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00190776435523MillenniumAvalign Technologies, Inc.HWM2026-10-20
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00190776437732MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437817MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776435127MillenniumAvalign Technologies, Inc.HWM2026-10-15
00190776435134MillenniumAvalign Technologies, Inc.HWM2026-10-15
00840277133915Innomed, Inc.INNOMED, INC.HWM2026-10-09
00190776434007MillenniumAvalign Technologies, Inc.HWM2026-10-08
00190776436223MillenniumAvalign Technologies, Inc.GFI2026-10-08
00190776436261MillenniumAvalign Technologies, Inc.HWM2026-10-08
G141548807040Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141548807060Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141549966080Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141646640020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
B7687715080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.HWM2026-10-06
00190776432935MillenniumAvalign Technologies, Inc.HWM2026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
G14164746930Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
G141647481020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
00190776432799MillenniumAvalign Technologies, Inc.GFI2026-09-29
00190776432805MillenniumAvalign Technologies, Inc.GFI2026-09-29
00190776432812MillenniumAvalign Technologies, Inc.HWM2026-09-29
00190776432713MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432720MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432737MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776431570MillenniumAvalign Technologies, Inc.HWM2026-09-22
00190776432102MillenniumAvalign Technologies, Inc.GFI2026-09-22