Wireless Probe Type Ultrasound Scanner

GUDID 06970672750043

Guangzhou Sonostar Technologies Co., Ltd.

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Primary Device ID	06970672750043
NIH Device Record Key	0d2c4cb3-87ef-47f6-90ee-c1f943b4372b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Wireless Probe Type Ultrasound Scanner
Version Model Number	BProbe
Company DUNS	543263098
Company Name	Guangzhou Sonostar Technologies Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970672750043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172750

FDA Product Code

IYO	System, Imaging, Pulsed Echo, Ultrasonic