FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780136484
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
440378
Catalog number
440-378
Device description
"Integra® Jarit® Ostrum Antrum Suction Punch, 4"", Pediatric Backward Cutting, Angled Left"
Published
2016-08-14
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
KAWPUNCH, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAWPunch, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780136484PrimaryGS10
M2744403781SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178013648410381780136484

GMDN Terms#

Term, Definition table
TermDefinition
ENT soft-tissue cutting forcepsA hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. It is not intended for cutting bone (i.e., not a rongeur). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch

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
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
10381780154501Integra® Ruggles®-Redmond™R2382R23822016-08-11
10381780154518Integra® Ruggles®-Redmond™R2384R23842016-08-11
10381780154525Integra® Ruggles®-Redmond™R2389R23892016-08-11
10381780154532Integra® Ruggles®-Redmond™R2396R23962016-08-11
10381780154549Integra® Ruggles®-Redmond™R2397R23972016-08-11
10381780154556Integra® Ruggles®-Redmond™R2398R23982016-08-11
10381780154563Integra® Ruggles®-Redmond™R2399R23992016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770508570Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508587Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508594Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508600Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508631Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508648Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00757770508662Bausch + LombBausch & Lomb IncorporatedKAW2026-04-30
00840183530730BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00840183530747BR Surgical, LLCBR Surgical, LLCKAW2025-08-26
00194613011499MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029326MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613029364MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047214MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613047221MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613061739MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081393MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613081447MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
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00194613081560MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613085568MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613088842MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613091507MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613094720MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613095062MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102104MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613102111MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613106171MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00194613123765MSI Precision Specialty InstrumentsMed Saver, Inc.KAW2025-08-01
00757770508563Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31
00757770508624Bausch + LombBausch & Lomb IncorporatedKAW2025-07-31