AccessGUDID - DEVICE: NGB-001 Needle-guided Bracket/VET (06944904017891)

GUDID

Device Identifier (DI) Information

Brand Name: NGB-001 Needle-guided Bracket/VET
Version or Model: PR1A-30-90603
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06944904017891
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58248	Ultrasound imaging system tracking positioner, reusable	A metal or plastic bracket intended to be applied to a hand-held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjunction with an EM 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. Disposable needle guides and imaging-supportive devices (e.g., US transducer cover/gel) may be included with the positioner; the transducer and sensor are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYN	System, imaging, pulsed doppler, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130695	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: b280977e-8662-4bca-839f-795886ad895e
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: September 20, 2016