AccessGUDID - DEVICE: LARYNGOTEC (04051948020977)

GUDID

Device Identifier (DI) Information

Brand Name: LARYNGOTEC
Version or Model: 15950-11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Andreas Fahl Medizintechnik-Vertrieb GmbH

Primary DI Number: 04051948020977
Issuing Agency: GS1
Commercial Distribution End Date: August 16, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 314768383 *Terms of Use

Device Description: LARYNGOTEC KOMBI Stoma Button FIX, SIZE 11

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:	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?
14093	Tracheostoma button	A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTO	Tube, Tracheostomy (W/Wo Connector)
BTR	Tube, Tracheal (W/Wo Connector)
JOH	Tube Tracheostomy And Tube Cuff

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 76f066b0-528f-4046-821f-4028a45e0e9a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2015