AccessGUDID - DEVICE: Provox2 Voice Prosthesis 15mm (07331791010057)

GUDID

Device Identifier (DI) Information

Brand Name: Provox2 Voice Prosthesis 15mm
Version or Model: 7224
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7224
Company Name: Atos Medical AB

Primary DI Number: 07331791010057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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 [?]
K971244	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 42 Degrees Celsius
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU.

Clinically Relevant Size

[?]

Size Type Text
Length: 15 Millimeter

Device Record Status

Public Device Record Key: ea52036f-b933-4ccd-b528-1a4bb7857ab9
Public Version Date: November 25, 2024
Public Version Number: 7
DI Record Publish Date: September 11, 2016