FDA.reportPublic FDA data

LARYNGOTEC

Primary DI
04051948065176
Brand
LARYNGOTEC
Company
Andreas Fahl Medizintechnik-Vertrieb GmbH
Model
15950-10
Device description
LARYNGOTEC KOMBI Stoma Button FIX, SIZE 10
Published
2016-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTOTube, Tracheostomy (W/Wo Connector)
BTRTube, Tracheal (W/Wo Connector)
JOHTube Tracheostomy And Tube Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051948065176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051948065176040519480651764051948065176

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostoma buttonA hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49220329800vertrieb@fahl.de

Regulatory Flags#

DUNS number
314768383
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04051948000061SILVERVENT10000-072015-09-17
04051948000122SILVERVENT10000-132015-09-17
04051948002676SILVERVENT10302-082016-03-16
04051948002683SILVERVENT10302-092016-03-16
04051948002690SILVERVENT10302-102016-03-16
04051948002706SILVERVENT10302-112016-03-16
04051948002713SILVERVENT10302-122016-03-16
04051948002720SILVERVENT10302-132016-03-16
04051948003161SILVERVENT10502-022016-03-16
04051948003178SILVERVENT10502-032016-03-16
04051948003185SILVERVENT10502-042016-03-16
04051948003192SILVERVENT10502-052016-03-16
04051948003208SILVERVENT10502-062016-03-16
04051948003215SILVERVENT10502-072016-03-16
04051948003222SILVERVENT10502-082016-03-16
04051948003239SILVERVENT10502-092016-03-16
04051948003246SILVERVENT10502-102016-03-16
04051948003253SILVERVENT10502-112016-03-16
04051948003260SILVERVENT10502-122016-03-16
04051948003277SILVERVENT10502-132016-03-16

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Primary DI, Brand, Company table
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