DEVICE: Provox® Vega™ Puncture Set (07331791009129)

Device Identifier (DI) Information

Provox® Vega™ Puncture Set
20 Fr
In Commercial Distribution
8144US
Atos Medical AB
07331791009129
GS1

1
355470923 *Terms of Use
The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
Yes
Yes
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
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FDA Product Code

[?]
Product Code Product Code Name
EWL Prosthesis, Laryngeal (Taub)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131947 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Length: 8 Millimeter
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Device Record Status

4bf71b79-cf3d-4d02-8e63-69279c848fdf
June 19, 2020
4
September 11, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4641519800
info@atosmedical.com
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