Sensonics' Snap & Sniff Eco-Friendly Olfactory Test System

Basic Information

• Brand Name: Sensonics' Snap & Sniff Eco-Friendly Olfactory Test System
• Primary DI: G051SST0
• Version / Model: SST
• Company Name: Sensonics, Inc.
• Labeler DUNS: 107213563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-11
• Public Version: 1
• Public Version Date: 2025-03-19
• Public Version Status: New
• Public Device Record Key: 9427be34-1e9b-4374-b4c1-c6a49cbbea98

Device Description

The Snap & Sniff® threshold test system was developed to provide scientists, clinicians, and others with a standardized, easy-to- use, and reliable means for assessing odor detection thresholds. In its standard form, the test employs the odorant phenyl ethyl alcohol (PEA), a stimulus with a rose-like smell at higher concentrations and little or no intranasal trigeminal nerve (CN V) reactivity. Other odorants, including n- butanol, ethyl acetate, guaiacol, pentyl (amyl) acetate, and phenyl ethyl methyl ethyl carbinol, are also available from Sensonics on a custom basis. The Snap & Sniff® threshold test kit is comprised of 20 smell “wands”. Five of these wands contain no odor, whereas the other wands contain, in the case of the standard odorant phenyl ethyl alcohol, half-log stimulus dilutions ranging from 10-2 (strongest) to 10-9 (weakest) concentrations. The odor of a given wand is contained within a cartridge similar to that of a felt-tip pen. When the thumb of the operator pushes forward on a slide mechanism, the odorized tip is exposed for sampling and presented to the subject. Releasing the slide retracts the odorized tip back into the wand’s housing. The Snap & Sniff® mechanism results in an easy presentation of an odorant to a subject. Because the odorant tip is presented only briefly, the odor is retained for much longer periods and can be used for testing many more subjects than devices lacking such sophisticated technology.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRK	Kit, Test, Olfactory	Ear, Nose, Throat	874.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G051SST0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]