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
10381780191070Integra® Jarit®400293400-2932018-04-02
10381780193180Integra® Jarit®P408P4082018-04-02
10381780197997Integra® Jarit®380232380-2322017-09-29
10381780198000Integra® Jarit®380233380-2332018-03-22
10381780198543Integra® Jarit®385295385-2952018-03-22
10381780220121Integra® Jarit®P666P6662018-01-31
10381780390381Integra® Jarit®380230380-2302018-02-16
10381780390398Integra® Jarit®380231380-2312018-02-16
10381780456469Integra® Jarit®405225405-2252018-01-31
10381780457190Integra® Jarit®P667P6672018-01-31
10381780458159Integra® Jarit®385315385-3152018-03-01
10381780458166Integra® Jarit®385316385-3162018-03-01
10381780487708Integra® Miltex®MH21-300MH21-3002018-08-22
10381780503910Integra® Miltex®PM-666PM-6662020-10-01
10381780520665CereLink™82684582-68452020-04-01
10381780087984Integra®375001237500122018-10-26
10381780081371Integra®372201137220112018-10-24
10381780081388Integra®372201237220122018-10-24
10381780081906Integra®372206937220692018-10-24
10381780081913Integra®372207037220702018-10-24

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