FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M2743856011
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
385-601
Catalog number
385601
Device description
T-Tube Inserter, 3-7/8", 1.2mm Diameter
Published
2018-05-02
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
JYMINSERTER, MYRINGOTOMY TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYMInserter, Myringotomy TubeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780391326PrimaryGS10
M2743856011SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178039132610381780391326

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tube inserterA device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as myringotomy tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. 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
DM exempt
false
Premarket exempt
true
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
00840183521844BR Surgical, LLCBR Surgical, LLCJYM2024-06-10
10381780074496Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-09-17
10381780391326Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
10381780391333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
10381780391340Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856051Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856061Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
00681490038263N/AMEDTRONIC XOMED, INC.JYM2017-09-10
00681490038270N/AMEDTRONIC XOMED, INC.JYM2017-09-10