AccessGUDID - DEVICE: Dunlee Sentinelle (00884838119826)

GUDID

Device Identifier (DI) Information

Brand Name: Dunlee Sentinelle
Version or Model: 989603216931
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838119826
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: VT1.5T 8CH TT TITAN FULL SET contains one box of 10 Biopsy grids, one Interface box, one Medial array, one Lateral array left and right, one Single loop left and right, one Medial plug and one Patient support.

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:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Atmospheric Pressure: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a7002a0-6168-4152-a361-747af2e3a480
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: May 23, 2023