DxTxMedical 1.5T eCoil Imaging System Disposables (Prostate)

GUDID 00850011472149

Disposable Prostate Probe 1.5T BPX 15

DXTX MEDICAL INC

MRI system coil, radio-frequency

• Primary Device ID: 00850011472149
• NIH Device Record Key: 0cae8e00-2a6d-40ae-9196-ca9d57348f38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxTxMedical 1.5T eCoil Imaging System Disposables (Prostate)
• Version Model Number: BPX 15
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011472149 [Primary]
GS1	10850011472146 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901888

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-12-11

Devices Manufactured by DXTX MEDICAL INC

• 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): 2020-03-05Disposable Prostate Probe 1.5T BPX 15
• 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