DEVICE: NGB-007 Needle-guided Bracket/PLAS (06944904001647)
Device Identifier (DI) Information
NGB-007 Needle-guided Bracket/PLAS
0022-30-90739
In Commercial Distribution
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
0022-30-90739
In Commercial Distribution
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
No description.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Ultrasound imaging system tracking holder | A non-sterile 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYN | System, imaging, pulsed doppler, ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K102991 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b9c51ae8-ec2c-4ed3-9bbc-85e489efcdfb
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+8675581888998
service@mindray.com.cn
service@mindray.com.cn