AccessGUDID - DEVICE: Sensonics' Microencapsulated Smell Tests (G051PSIT9)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: G051PSIT9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107213563 *Terms of Use

Device Description: The Pocket Smell Tests provide a quick 3-, 4-, 6-, or 8-odor forced-choice screening test using the same microencapsulated odorant technology as the Smell Identification Test. It is a very brief screen for gross olfactory dysfunction. If the test subject misses one or more of the test items, then the 40-item Smell Identification Test™ should be given to accurately quantify the degree of smell loss.

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: 68d30eed-2372-4f61-85d3-b871d8047fe9
Public Version Date: February 06, 2025
Public Version Number: 1
DI Record Publish Date: January 29, 2025