AccessGUDID - DEVICE: Sniffin' Sticks - Extended Test (04260676240124)

GUDID

Device Identifier (DI) Information

Brand Name: Sniffin' Sticks - Extended Test
Version or Model: LA-13-00435
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LA-13-00435
Company Name: Burghart Messtechnik GmbH

Primary DI Number: 04260676240124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341406604 *Terms of Use

Device Description: The Extended Test (also called “TDI-Test“ – Threshold, Discrimination, Identification) consists of 3 individual tests. A threshold test, a discrimination test and an identi-fication test. Each of these tests generates a number of points, which is added up to the TDI score at the end. The user is given a diagnostic classification of the patient's ability to smell. This is done by evaluating the number of points achieved. For the score, also called TDI score, there are standard values, which were determined by a validation study. The maximum number of points is 48, which is divided between the 3 tests.

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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae9d3d4a-3b56-48f9-9c81-a92380cf6633
Public Version Date: April 21, 2021
Public Version Number: 2
DI Record Publish Date: November 10, 2020