OKB OTC Hearing Aid 30-81-0300-0103

GUDID 00193169001602

Air-conduction hearing aid, in-the-ear

Primary Device ID	00193169001602
NIH Device Record Key	d4dea434-ba0c-49a3-b12d-fa04fde1b5e9
Commercial Distribution Status	In Commercial Distribution
Brand Name	OKB OTC Hearing Aid
Version Model Number	GV-SA03.60
Catalog Number	30-81-0300-0103
Company DUNS	658796458
Company Name	OK BIOTECH CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00193169001602 [Primary]
GS1	00193169003606 [Package] Package: Kit [1 Units] In Commercial Distribution

QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Steralize Prior To Use	false
Device Is Sterile	false

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