AccessGUDID - DEVICE: Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®) (00850011472149)

GUDID

Device Identifier (DI) Information

Brand Name: Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)
Version or Model: BPX 15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BPX 15
Company Name: DXTX MEDICAL INC

Primary DI Number: 00850011472149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082448484 *Terms of Use

Device Description: Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®), alternate Philips package catalog number 4522-132-70682 for box of 5

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
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
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K901888	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: 0cae8e00-2a6d-40ae-9196-ca9d57348f38
Public Version Date: May 23, 2024
Public Version Number: 3
DI Record Publish Date: December 11, 2019