DxTx Medical 1.5T eCoil Imaging Device (for GE)

GUDID 00850011472224

Ecoil ID - 1.5T GE - M64ERA8-P

DXTX MEDICAL INC

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• Primary Device ID: 00850011472224
• NIH Device Record Key: 96d8a3fc-f31a-4755-be0e-0f05638e0875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxTx Medical 1.5T eCoil Imaging Device (for GE)
• Version Model Number: M64ERA8-P
• Company DUNS: 082448484
• Company Name: DXTX MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011472224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053042

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

Devices Manufactured by DXTX MEDICAL INC

• 00850011472224 - DxTx Medical 1.5T eCoil Imaging Device (for GE): 2021-04-13Ecoil ID - 1.5T GE - M64ERA8-P
• 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): 2020-03-05 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
• 10850011472160 - DxTx Medical 1.5 eCoil Imaging System Disposables (Prostate Bulk 50/bx): 2020-03-05 Disposable Prostate Probe - 1.5T - BPX15-50
• 10850011472177 - DxTx Medical 3T eCoil Imaging System Disposables (Prostate): 2020-03-05 Disposable Prostate Probe - 3.0T - BPX-30