AccessGUDID - DEVICE: Provox FenestrationPunch (07331791002632)

GUDID

Device Identifier (DI) Information

Brand Name: Provox FenestrationPunch
Version or Model: 7654
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7654
Company Name: Atos Medical AB

Primary DI Number: 07331791002632
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTF	Punch, Ent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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 dry. Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 229af426-0c5a-4948-af60-7775305e98c9
Public Version Date: July 19, 2024
Public Version Number: 3
DI Record Publish Date: November 25, 2022