DEVICE: LARYNGOTEC (04051948020755)
Device Identifier (DI) Information
LARYNGOTEC
15905-08
Not in Commercial Distribution
Andreas Fahl Medizintechnik-Vertrieb GmbH
15905-08
Not in Commercial Distribution
Andreas Fahl Medizintechnik-Vertrieb GmbH
LARYNGOTEC Stoma Button, SIZE 8
Device Characteristics
MR Safe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
14093 | Tracheostoma button |
A 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JOH | Tube Tracheostomy And Tube Cuff |
BTR | Tube, Tracheal (W/Wo Connector) |
BTO | Tube, Tracheostomy (W/Wo Connector) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
043f2d84-a60f-4d45-932c-99d27c878f72
October 13, 2021
3
August 17, 2016
October 13, 2021
3
August 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49220329800
vertrieb@fahl.de
vertrieb@fahl.de