FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2744404101
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
440-410
Device description
SINUS SICKLE KNIFE
Published
2016-08-14
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)
KTGKNIFE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
KTGKnife, EntEar, 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
10381780145660PrimaryGS10
M2744404101SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178014566010381780145660

GMDN Terms#

Term, Definition table
TermDefinition
Nasal knifeA hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800300Adler Instrument CompanyAdler, Inc.KTG2026-06-02
00840319759011Hayden MedicalHayden Medical, Inc.EOB2026-05-01
04719872715016MiiS Horus scopeMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
04719872715023MiiS Horus Video BoxMEDIMAGING INTEGRATED SOLUTION INC.EOB2026-04-29
00840343727550Gen2SURGIX MEDICAL LLCKTG2026-04-22
00840343727314GEN2SURGIX MEDICAL LLCKTG2026-04-16
00840343727321GEN2SURGIX MEDICAL LLCKTG2026-04-16
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
M6334951040JEDMEDJEDMED INSTRUMENT COMPANYEOB2023-05-09
10818634025132AmbuBosma EnterprisesEOB2023-05-01
00860009626805VISIONAIRPACIFICMD BIOTECH, LLCEOB2023-02-07
M6334951120JEDMEDJEDMED INSTRUMENT COMPANYEOB2023-01-19
14026704804617PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804693PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804761PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804778PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804785PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804792PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804808PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804853PILLINGTELEFLEX INCORPORATEDKTG2022-12-08
14026704804884PILLINGTELEFLEX INCORPORATEDKTG2022-12-08