AccessGUDID - DEVICE: Sensonics' Waterless Taste Test Strips (G051WETTSA270)

GUDID

Device Identifier (DI) Information

Brand Name: Sensonics' Waterless Taste Test Strips
Version or Model: WETT-SA27
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sensonics, Inc.

Primary DI Number: G051WETTSA270
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107213563 *Terms of Use

Device Description: The Brief Self-Administered Waterless Empirical Taste Test™ (WETT®-SA27) is an easy and inexpensive method for quantitatively evaluating taste function. Delivery of tastants is via disposable plastic strips with proprietary pads of monomer cellulose that are embedded with either sucrose (sweet), citric acid (sour), sodium chloride (salty), caffeine (bitter), monosodium glutamate (umami), or blank tastants. No liquid rinsing is required. The test strips are located in two pouches or packages from which they can be individually removed for testing. The first pack contains strips numbered from 1 to 13 and the second contains strips numbered 14 to 27.

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:	Yes
Prescription Use (Rx):	No
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?
65155	Gustatory test stick	A non-powered, flavoured device intended to be used to assess a patient’s gustatory function (sense of taste). It typically consists of a flavoured stick(s) intended to be placed on the tongue of the patient, followed by patient description of taste perception. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNJ	Gustometer, Non-Sterile

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: 338bb2c4-7d13-48c2-a472-9ae49cfbe2d1
Public Version Date: February 06, 2025
Public Version Number: 1
DI Record Publish Date: January 29, 2025