AccessGUDID - DEVICE: 6LB7s Ultrasonic Transducer(FDA) (06944904088693)

GUDID

Device Identifier (DI) Information

Brand Name: 6LB7s Ultrasonic Transducer(FDA)
Version or Model: PB1A-30-90878
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06944904088693
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Rectal ultrasound imaging system transducer	An ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also known as a rectal, transrectal, or prostate probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Rectal ultrasound imaging system transducer

An ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. Also known as a rectal, transrectal, or prostate probe, it may incorporate a biopsy needle guidance channel as part of the transducer casing or housing assembly design. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a38dffc2-31fd-42d3-8554-b821a760811b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016