FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780200086
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
430220
Catalog number
430-220
Device description
"Integra® Jarit® Ronis Adenoid Punch, 5-1/8"", 6mm bite, Triangular End, Curved Up, #0"
Published
2018-01-24
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
KBSPUNCH, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBSPunch, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780200086PrimaryGS10
M2744302201SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178020008610381780200086

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.

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

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00757770508723Bausch + LombBausch & Lomb IncorporatedKBS2026-04-30
00757770508693Bausch + LombBausch & Lomb IncorporatedKBS2025-08-07
00757770508716Bausch + LombBausch & Lomb IncorporatedKBS2025-08-07
04049197474801RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKBS2024-09-20
04049197474818RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKBS2024-09-20
00840183509415BR Surgical, LLCBR Surgical, LLCKBS2024-06-03
00840183512408BR Surgical, LLCBR Surgical, LLCKBS2024-06-03
00842331195471Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
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00842331194412Novo Surgical Inc. NOVO SURGICAL, INC.KBS2023-12-07
00842331194429Novo Surgical Inc. NOVO SURGICAL, INC.KBS2023-12-07
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00842962149591HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
00842962149607HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
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00840319742846Hayden MedicalHayden Medical, Inc.KBS2023-03-14
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