FDA.reportPublic FDA data

NGB-003 Needle-guided Bracket/DETACH/VET

Primary DI
06944904054100
Brand
NGB-003 Needle-guided Bracket/DETACH/VET
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
115-002027-00
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111435000DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011-07-08IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944904054100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944904054100069449040541006944904054100

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system tracking holder, reusableA device intended to be used with a hand-held ultrasound (US) imaging system transducer to provide a means to attach/hold an electromagnetic (EM) sensor or needle guide to the distal end of the US transducer in a repeatable position (can detach/reattach to same place on transducer). It is a metal/plastic bracket available in various dimensions that is manually applied to the US transducer. It is typically used in conjunction with an electromagnetic device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. This is a reusable device.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+8675581888998service@mindray.com.cn

Regulatory Flags#

DUNS number
654671304
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944904003825CABLE,IBP ADAPTER, 12PIN/6PIN0010-20-427952016-09-23
06944904003856CABLE,XDUCER,IBP,EDWARD,12PIN0010-21-121792016-09-23
06944904003870CABLE,XDUCER,IBP,MEMSCAP,6PIN0010-21-430812016-09-23
06944904003887CABLE,XDUCER,IBP,MEMSCAP,12PIN0010-21-430822016-09-23
06944904003894CABLE,XDUCER,IBP,EDWARD,6PIN0010-21-430942016-09-23
06944904030838ECG adapter cable (12-pin to 6-pin)0010-30-430542016-09-23
06944904030272A5 Anesthesia SystemA52015-10-20
06944904039695A7 Anesthesia SystemA72015-10-20
06903053124348Diagnostic Ultrasound SystemMU9 Pro2026-06-03
06903053124355Diagnostic Ultrasound SystemMU9A2026-06-03
06903053124379Diagnostic Ultrasound SystemMU7 Pro2026-06-03
06903053124430Diagnostic Ultrasound SystemMU9 Super2026-06-03
06903053124461Diagnostic Ultrasound SystemMU72026-06-03
06903053124492Diagnostic Ultrasound SystemMU7 Super2026-06-03
06903053124546Diagnostic Ultrasound SystemMU9S2026-06-03
06903053124560Diagnostic Ultrasound SystemMU9P2026-06-03
06903053124591Diagnostic Ultrasound SystemMU92026-06-03
06903053124607Diagnostic Ultrasound SystemMU7S2026-06-03
06903053124614Diagnostic Ultrasound SystemMU7A2026-06-03
06903053124683Diagnostic Ultrasound SystemMU9T2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953113493LOGIQGE Ultrasound Korea Ltd.IYO2026-01-21
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953042731LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05