FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780190967
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
400235
Catalog number
400-235
Device description
"Integra® Jarit® Wiener Antrum Rasp, 7-3/4"", Medium, 4mm Wide, Trocar Tip"
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
KAZRASP, FRONTAL-SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAZRasp, Frontal-SinusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780190967PrimaryGS10
M2744002351SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019096710381780190967

GMDN Terms#

Term, Definition table
TermDefinition
Frontal sinus file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape, clean out, and enlarge the frontal sinus cavities during ear/nose/throat (ENT) surgery. It is available in two main designs: 1) a one-piece instrument that has circular cutting ridges at the tip of the curved distal working end and a handle at the proximal end; or 2) a tubular construction that allows for integrated suction (a tube from a suction system is connected to its proximal end) and a rasp (e.g., diamond coating) at the contoured working end. It is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width4Millimeter

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
Primary DIBrandCompanyProduct codePublished
00885556869017Kompressor Compression Screw SystemSmith & Nephew, Inc.KAZ2022-12-22
10381780080190Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-09-17
10381780080206Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-09-17
24026704505801PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
24026704506679PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
24026704527049PILLINGTELEFLEX INCORPORATEDKAZ2018-09-15
10381780190950Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190974Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780190981Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002341Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002351Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002361Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
M2744002371Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-04-02
10381780421856Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
10381780421863Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
10381780421870Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203780Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
H834203820Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAZ2018-01-12
00849233014589Busse Hospital DisposablesROBERT BUSSE & CO., INC.KAZ2016-09-14