AccessGUDID - DEVICE: TELESIS® (00852423006431)

GUDID

Device Identifier (DI) Information

Brand Name: TELESIS®
Version or Model: 9250-ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9250-ST
Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Primary DI Number: 00852423006431
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625863568 *Terms of Use

Device Description: 9250-ST Telesis® ST Software for Speech Therapy MR Series

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:	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?
44574	Biofeedback system application software	An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

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: 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: be440029-f8c9-4447-a469-2a9f56bc6226
Public Version Date: July 18, 2024
Public Version Number: 2
DI Record Publish Date: October 03, 2019