FDA.reportPublic FDA data

Integra®

Primary DI
10381780074496
Brand
Integra®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
1316005
Catalog number
1316005
Device description
"Integra® Goode T-Tube Inserter Forceps, 3-3/8"", Stainless Steel, Satin Finish"
Published
2018-09-17
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
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
10381780074496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007449610381780074496

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
00840183521844BR Surgical, LLCBR Surgical, LLCJYM2024-06-10
10381780391326Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
10381780391333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
10381780391340Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYM2018-05-02
M2743856011Integra® 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