FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780407003
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X31419
Catalog number
X31419
Device description
"Mosher Ethmoid Curette 9"", Double-Ended, Oval Cups, Graduated Shaft"
Published
2018-05-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAPCURETTE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAPCurette, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780407003PrimaryGS10
M274X314191SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178040700310381780407003

GMDN Terms#

Term, Definition table
TermDefinition
Ethmoid curetteA slender, hand-held, manual surgical instrument designed for excision of the ethmoid cells (spaces in the ethmoid sinuses) or a portion of the ethmoid bone (i.e., ethmoidectomy). The instrument typically has two ring-shaped ends that are usually sharp on both sides; it is typically 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
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

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Primary DI, Brand, Company table
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09348811100382INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
09348811100979INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
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00887482116203Symmetry PaparellaASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
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