AccessGUDID - DEVICE: Sniffin' Sticks - Screening 12 Test Refill Set (04260676240155)

GUDID

Device Identifier (DI) Information

Brand Name: Sniffin' Sticks - Screening 12 Test Refill Set
Version or Model: LA-13-00437
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LA-13-00437
Company Name: Burghart Messtechnik GmbH

Primary DI Number: 04260676240155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341406604 *Terms of Use

Device Description: The Screening 12 Test is intended to be used for examination of smell disorders on humans. The test result can be used to differentiate between Normosmia, Hyposmia, and Anosmia, if the patient is cooperative.

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 966f10ba-4b71-46b2-a3be-8b17e38a5573
Public Version Date: April 29, 2021
Public Version Number: 1
DI Record Publish Date: April 21, 2021