AccessGUDID - DEVICE: Provox XtraFlange 22.5 (07331791006920)

GUDID

Device Identifier (DI) Information

Brand Name: Provox XtraFlange 22.5
Version or Model: 7275
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7275
Company Name: Atos Medical AB

Primary DI Number: 07331791006920
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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 [?]
K092593	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
Device Size Text, specify: Voice Prosthesis Compatibility Fits 22.5 Fr voice prosthesis

Device Record Status

Public Device Record Key: 1f88972c-1a53-4544-abe7-46200d36c859
Public Version Date: November 25, 2024
Public Version Number: 7
DI Record Publish Date: September 11, 2016