DEVICE: Sensonics' Snap & Sniff Eco-Friendly Olfactory Test System (G051SNSD0)

Device Identifier (DI) Information

Sensonics' Snap & Sniff Eco-Friendly Olfactory Test System
SNSD
Not in Commercial Distribution

Sensonics, Inc.
G051SNSD0
HIBCC
March 11, 2025
1
107213563 *Terms of Use
The Sensonics’ S&S-D test is a member of Snap & Sniff® Olfactory Testing System. This test, along with the other members of the Snap & Sniff® family, was developed to provide scientists, clinicians, and others with a standardized, easy-to-use, and reliable means for evaluating the ability of subjects to discriminate odors. Detailed instructions are provided in an accompanying manual to minimize variability in test administration. The test employs the following odorants: phenyl ethyl alcohol; anethole; amyl acetate; and guaiacol. Formulated at iso-intensive levels, the wands are presented in groups of 3 and the subject is asked to choose which of the 3 is different. The presentation pattern is intuitive and easy to follow. The Snap & Sniff® Discrimination Test kit is comprised of 20 smell “wands”. The odor of a given wand is contained within a proprietary odor-emitting cartridge. 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. Liquids, per se, are not present in the sniff wands.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
NRK Kit, Test, Olfactory
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

bad1cf85-2338-4a07-a795-33b35f3ecc21
March 12, 2025
2
January 29, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
856-547-7702
sales@sensonics.com
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