DEVICE: Provox® XtraFlange™ (07331791006937)
Device Identifier (DI) Information
Provox® XtraFlange™
20 Fr
In Commercial Distribution
7276
Atos Medical AB
20 Fr
In Commercial Distribution
7276
Atos Medical AB
Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa.
The device is supplied sterile and is intended for single use only.
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
42533 | Tracheoesophageal speech valve, indwelling |
A device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The patient periodically cleans the device in situ. Disposable devices associated with implantation/insertion may be included. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EWL | Prosthesis, Laryngeal (Taub) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092593 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry. Keep away from sunlight. |
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Lumen/Inner Diameter: 6.6 Millimeter |
Device Record Status
806722a5-32a7-4508-8a45-32e180e0464a
June 19, 2020
4
September 11, 2016
June 19, 2020
4
September 11, 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
[?]
+4641519800
info@atosmedical.com
info@atosmedical.com