FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2744404061
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
440-406
Device description
ANTRUM CURETTE
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
KAPCURETTE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
KAPCurette, NasalEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941565000JARIT RECOMMENDED SINUS INSTRUMENTSJ. Jamner Surgical Instruments, Inc.1994-05-16EOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780129219PrimaryGS10
M2744404061SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012921910381780129219

GMDN Terms#

Term, Definition table
TermDefinition
Salpingeal curetteA slender, hand-held, surgical instrument that is used to clear blockages of the Eustachian tube during an ear/nose/throat (ENT) procedure. It is typically made of high-grade stainless steel and can be either rigid or malleable (bendable) and has a small, half-rounded, head terminating in a sharp scraping edge at its widest diameter at the curved distal end of a long shaft which has a handle at the proximal end. The scraping tip is available in various shapes and sizes. This is a reusable device.

Device Sizes#

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

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00858119004194Entity XL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004200Entity SDXL Plus NasopharyngoscopeOPTIM LLCEOB2024-06-19
00858119004217Entity XL USB NasopharyngoscopeOPTIM LLCEOB2024-06-19
00821925041462InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041479InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041486InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041493InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041509InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041516InstaClearGyrus ACMI, LLCEOB2024-04-22
00821925041523InstaClearGyrus ACMI, LLCEOB2024-04-22
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EOB2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.EOB2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.EOB2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.EOB2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.EOB2023-07-04
M6334951040JEDMEDJEDMED INSTRUMENT COMPANYEOB2023-05-09
10818634025132AmbuBosma EnterprisesEOB2023-05-01
00860009626805VISIONAIRPACIFICMD BIOTECH, LLCEOB2023-02-07
M6334951120JEDMEDJEDMED INSTRUMENT COMPANYEOB2023-01-19
00818501022397Clearview Scope CoverINVOTEC INTERNATIONAL, INC.EOB2022-12-06
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.EOB2021-12-17
10886705031658NAMedos International SàrlEOB2021-05-20
10886705031665NAMedos International SàrlEOB2021-05-20
10886705031900NAMedos International SàrlEOB2021-05-20
10886705031955NAMedos International SàrlEOB2021-05-20
10886705031986NAMedos International SàrlEOB2021-05-20
10886705031993NAMedos International SàrlEOB2021-05-20