AccessGUDID - DEVICE: Integrity Bone Conductor (00627908010032)

GUDID

Device Identifier (DI) Information

Brand Name: Integrity Bone Conductor
Version or Model: B71-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vivosonic Inc

Primary DI Number: 00627908010032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201740425 *Terms of Use

Device Description: Bone conductor for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

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:	No
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?
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
EWO	Audiometer
GWJ	Stimulator, Auditory, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043396	000

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: 46e40a2c-ff14-4177-9014-4d2831aabf66
Public Version Date: April 21, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016