FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780192695
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
400OBT297
Catalog number
400-OBT-297
Device description
Integra® Jarit® Replacement Obturator For Ref# 400-297
Published
2018-04-03
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
KADELEVATOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780192695PrimaryGS10
M274400OBT2971SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019269510381780192695

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. 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
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
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04046826112790MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAD2026-03-04
00190776415945MillenniumAvalign Technologies, Inc.KAD2026-02-06
00757770425143Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
00757770636822Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
09348811101587INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-28
00810207783039Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783046Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
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00810207783152Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
09348811101501INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
09348811101532INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
00757770636341Bausch + LombBausch & Lomb IncorporatedKAD2025-11-15
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