AccessGUDID - DEVICE: Sensonics' Microencapsulated Smell Tests (G051PIT0)

GUDID

Device Identifier (DI) Information

Brand Name: Sensonics' Microencapsulated Smell Tests
Version or Model: PIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PIT
Company Name: Sensonics, Inc.

Primary DI Number: G051PIT0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107213563 *Terms of Use

Device Description: A research tool for screening cognitive confounds. This 40-item test is equivalent to the SIT™ except that pictures, rather than odors, are used as stimuli. Provides a control, in experimental settings, for non-olfactory components of the SIT. Can be used multiple times.

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?
65154	Olfactory test stick	A non-powered, scented device intended to be used to assess a patient’s olfactory function (normosmia, hyposmia, or anosmia). It typically consists of a scented stick(s) intended to be sniffed by the patient, followed by patient description of smell perception. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRK	Kit, Test, Olfactory

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: 9564b888-ab6b-4ef7-9829-0a894ea70804
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025