NGB-034 Needle-guided Bracket

GUDID 06944904091884

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Ultrasound imaging system tracking holder, reusable
Primary Device ID06944904091884
NIH Device Record Keyc0674191-cb80-409a-94e2-e46c1a73454d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNGB-034 Needle-guided Bracket
Version Model Number120-004404-00
Company DUNS654671304
Company NameShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944904091884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


[06944904091884]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-23
Device Publish Date2018-08-03

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

06903053001403 - Trolley2024-12-30
06936415985462 - BeneVision N12 OR Patient Monitor2024-12-19
06936415919283 - uMEC6 Patient Monitor2024-12-02
06936415903527 - VS-900c Vital Signs Monitor2024-11-28
06936415980702 - A3 Anesthesia Delivery System2024-11-28
06944904040301 - VS-900 Vital Signs Monitor2024-11-28
06944904097923 - cPM 8 Patient Monitor2024-11-28
06944904097930 - cPM 12 Patient Monitor2024-11-28

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.