AccessGUDID - DEVICE: Senti Set 2 (04260223142963)

GUDID

Device Identifier (DI) Information

Brand Name: Senti Set 2
Version or Model: 100450
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PATH medical GmbH

Primary DI Number: 04260223142963
Issuing Agency: GS1
Commercial Distribution End Date: January 20, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 551540334 *Terms of Use

Device Description: Senti Audiometry (Class 3) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Headphone HDA-280 AN100117 7. Bone conductor B71 with patient response button AN100214 8. Power supply AN100083 9. USB data cable AN100089

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:	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?
37503	Tone audiometer	An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

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: 538d5868-770f-4379-b04e-581ace4bb3bd
Public Version Date: August 03, 2023
Public Version Number: 3
DI Record Publish Date: May 14, 2018