AccessGUDID - DEVICE: Accessory box AB03 (04260223143380)

GUDID

Device Identifier (DI) Information

Brand Name: Accessory box AB03
Version or Model: 100261-BL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PATH medical GmbH

Primary DI Number: 04260223143380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 551540334 *Terms of Use

Device Description: Accessory Set with Bio-Logic Branding including: 4pcs. 100013 Probe Tip PT-A 4pcs. 100014-W Probe Tip PT-S 1pc. 100129 Test Cavity PT-A 1pc. 100160 Test Cavity PT-S 10pcs. 100063 Ear Tip ET-03 10pcs. 100064 Ear Tip ET-10 7pcs 100125 Ear Tip ET-11 5pcs. 100839 Ear Tip Soft ET-17 6pcs. 100838 Ear Tip Soft ET-16 10pcs. 100144 Ear Tip ET-13 4pcs. 100230 Ear Tip Soft ET-14 10pcs. 100030 Ear Tip ET-S02 10pcs. 100031 Ear Tip ET-S03 10pcs. 100032 Ear Tip ET-S10 10pcs. 100840 Ear Tip Soft ET-S11 1pc. 100151 Cleaning Tool CT-01

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):	Yes
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61378d5c-1b42-409f-8a62-2138856d4b54
Public Version Date: May 18, 2018
Public Version Number: 1
DI Record Publish Date: April 17, 2018