AccessGUDID - DEVICE: CW 8MHz Ultrasonic Probe (07290016734065)

GUDID

Device Identifier (DI) Information

Brand Name: CW 8MHz Ultrasonic Probe
Version or Model: CW 8MHz Ultrasonic Probe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23-635
Company Name: RIMED LTD.

Primary DI Number: 07290016734065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600054688 *Terms of Use

Device Description: The CW 8MHz Ultrasonic Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the RIMED's Transcranial Doppler System.

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40768	Extracorporeal ultrasound imaging transducer, hand-held	A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). 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 an ultrasound system controller for image processing and display. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062578	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: 9bddefaf-b73b-4c26-a0e3-67854858cf8d
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016