AccessGUDID - DEVICE: NA (B318PACCGS15HDX1)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: PACC-GS15-HDx
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PACC-GS15-HDx
Company Name: Machnet B.V.

Primary DI Number: B318PACCGS15HDX1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 416060564 *Terms of Use

Device Description: Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imaging of the carotids bifurcation. The Carotids Coil enables sub-millimeter resolution of the carotids lumen, vessel walls and atherosclerotic plaques. Compatible with GE Signa HDx 1.5T scanners.

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):	No
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?
40749	MRI system coil, radio-frequency	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOS	Coil, Magnetic Resonance, Specialty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012491	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: 36920288-ce3b-411d-92d9-ced67d064f14
Public Version Date: March 05, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016