16Ch Diagnostic Breast Coil

GUDID 04260487680188

1.5T 16Ch Diagnostic Breast Coil (MP Kit)

RAPID Biomedical GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04260487680188
• NIH Device Record Key: cd250aae-54d7-4478-8227-4afc50fd9058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16Ch Diagnostic Breast Coil
• Version Model Number: P-H16LE-015-01894
• Company DUNS: 316037741
• Company Name: RAPID Biomedical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260487680188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181948

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2019-08-23

On-Brand Devices [16Ch Diagnostic Breast Coil]

• 04260487680188: 1.5T 16Ch Diagnostic Breast Coil (MP Kit)
• 04260487680171: 3.0T 16Ch Diagnostic Breast Coil (MP Kit)