AccessGUDID - DEVICE: NGB-007 Needle-guided Bracket/PLAS (06944904001647)

GUDID

Device Identifier (DI) Information

Brand Name: NGB-007 Needle-guided Bracket/PLAS
Version or Model: 0022-30-90739
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06944904001647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654671304 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b9c51ae8-ec2c-4ed3-9bbc-85e489efcdfb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016