AccessGUDID - DEVICE: Volume probe (06945121409858)

GUDID

Device Identifier (DI) Information

Brand Name: Volume probe
Version or Model: V6-EV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHISON Medical Technologies Co., Ltd.

Primary DI Number: 06945121409858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544914187 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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
Rectal/vaginal ultrasound imaging transducer	An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Rectal/vaginal ultrasound imaging transducer

An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162172	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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 48e1329e-5572-4fd2-bc5a-261a86914f3f
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016