AccessGUDID - DEVICE: Sentiero Desktop Screening (04260223141478)

GUDID

Device Identifier (DI) Information

Brand Name: Sentiero Desktop Screening
Version or Model: 100497-US1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PATH medical GmbH

Primary DI Number: 04260223141478
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 551540334 *Terms of Use

Device Description: Sentiero Desktop Screening Set US1 Sentiero Desktop Screening Set Tymp with IPSI Reflex Content: 1. Sentiero Desktop (Tymp Screening) AN100434-SB 2. USB data cable AN100418 3. Probe EP-TY long AN100188-US 4. FW Screening Tymp class 2 AN100560 5. Software label printer AN100414 6. Accessory box for Tymp probe AN100587 7. Accessory box Sentiero (Grason) AN100734 8. Power supply Senti / Sentiero Desktop FW7662M AN100524 9. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS. AN100525-USA/-UK/-EU/-AUS 10. Test cavity tymp AN100549

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

GMDN Preferred Term Name

GMDN Definition

Evoked-potential audiometer

An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

FDA Product Code

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Product Code	Product Code Name
EWO	Audiometer
GWJ	Stimulator, Auditory, Evoked Response
ETY	Tester, Auditory Impedance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133012	000

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: 332c20c5-651a-49fb-a962-5a466e2879f1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016