DxTx Medical 1.5T eCoil Imaging System Disposables (Prostate - Philips)

GUDID 10850011472122

Disposable Prostate Probe - 1.5T Philips - 4522-132-70681

DXTX MEDICAL INC

MRI system coil, radio-frequency
Primary Device ID10850011472122
NIH Device Record Key2b5eab67-3a81-492b-8834-6ed6ea0a4c26
Commercial Distribution StatusIn Commercial Distribution
Brand NameDxTx Medical 1.5T eCoil Imaging System Disposables (Prostate - Philips)
Version Model Number4522-132-70681
Company DUNS082448484
Company NameDXTX MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011472125 [Primary]
GS110850011472122 [Package]
Contains: 00850011472125
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-05
Device Publish Date2019-12-11

Devices Manufactured by DXTX MEDICAL INC

00850011472019 - 1.5T Ingenia Endorectal Coil Interface Device (eCoil®)2024-05-23 1.5T Ingenia Endorectal Coil Interface Device (eCoil®) - Philips
00850011472088 - 1.5T Ingenia Endorectal Coil Interface Device System (eCoil®)2024-05-23 1.5T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips
00850011472095 - 3.0T Ingenia Endorectal Coil Interface Device (eCoil®)2024-05-23 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) - Philips
00850011472101 - 3.0T Ingenia Endorectal Coil Interface Device System (eCoil®)2024-05-23 3.0T Ingenia Endorectal Coil Interface Device System (eCoil®) - Philips
00850011472224 - DxTx Medical 1.5T eCoil Imaging Device (for GE)2021-04-13 Ecoil ID - 1.5T GE - M64ERA8-P
10850011472115 - DxTx Medical 3T eCoil Imaging System Disposables (Prostate - Philips)2020-03-05 Disposable Prostate Probe - 3.0T Philips - 4522-132-64751
10850011472122 - DxTx Medical 1.5T eCoil Imaging System Disposables (Prostate - Philips)2020-03-05Disposable Prostate Probe - 1.5T Philips - 4522-132-70681
10850011472122 - DxTx Medical 1.5T eCoil Imaging System Disposables (Prostate - Philips)2020-03-05 Disposable Prostate Probe - 1.5T Philips - 4522-132-70681
00850011472149 - DxTxMedical 1.5T eCoil Imaging System Disposables (Prostate)2020-03-05 Disposable Prostate Probe 1.5T BPX 15

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