FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780419334
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-246
Catalog number
19-246
Device description
"Hartman Eustachian Catheter 5-5/8"", Bulbous Tip, 3.5mm Diameter, Size 2"
Published
2017-12-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBYCATHETER, EUSTACHIAN, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBYCatheter, Eustachian, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780419334PrimaryGS10
H834192460SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178041933410381780419334

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, reusableA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. 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
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02
10381780519089CODMAN® HAKIM®82309782-30972020-06-02
10381780519195CODMAN® HAKIM®82311682-31162020-06-02
10381780519249CODMAN® HAKIM®82316482-31642020-06-02
10381780519256CODMAN® HAKIM®82318282-31822020-06-02
10381780519263CODMAN® HAKIM®82318482-31842020-06-02
10381780519447CODMAN® HAKIM®82328182-32812020-06-02
10381780519478CODMAN® HAKIM®82328482-32842020-06-02
10381780519485CODMAN® HAKIM®82328582-32852020-06-02
10381780519751CODMAN® HAKIM®82382182-38212020-06-02
10381780519768CODMAN® HAKIM®82382282-38222020-06-02
10381780519799CODMAN® HAKIM®82382582-38252020-06-02
10381780519805CODMAN® HAKIM®82383282-38322020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653176243AESCULAPAesculap AGGBY2020-04-22
04038653176250AESCULAPAesculap AGGBY2020-04-22
04038653176267AESCULAPAesculap AGGBY2020-04-22
04038653176281AESCULAPAesculap AGGBY2020-04-22
00888118057686CATHETERKLS-Martin L.P.GBY2018-09-26
00888118057693CATHETERKLS-Martin L.P.GBY2018-09-26
00888118057709CATHETERKLS-Martin L.P.GBY2018-09-26
10381780402916Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
10381780402923Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
M274X203531Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
M274X203571Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2018-05-03
10381780419327Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
H834192420Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21
H834192460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGBY2017-12-21