AccessGUDID - DEVICE: Sanibel Supply (05711117229783)

GUDID

Device Identifier (DI) Information

Brand Name: Sanibel Supply
Version or Model: TM electrode for ECochG, starter kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8013209
Company Name: Interacoustics A/S

Primary DI Number: 05711117229783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306308354 *Terms of Use

Device Description: Medical device accessories intended for ABR measurements

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:	Yes
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?
35747	Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWJ	Stimulator, Auditory, Evoked Response

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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 27 Degrees Celsius
Storage Environment Temperature: between 60 and 80 Degrees Fahrenheit
Handling Environment Humidity: between 60 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 619d0a5e-1150-42f6-b7e2-0b6b197bcff2
Public Version Date: January 06, 2023
Public Version Number: 1
DI Record Publish Date: December 29, 2022