16Ch AI BREAST COIL 3T

GUDID 04260487680041

RAPID Biomedical GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04260487680041
• NIH Device Record Key: 4814c4b7-0c4f-42ce-b366-e1ad269ba6ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16Ch AI BREAST COIL 3T
• Version Model Number: 10185782 02
• 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 Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260487680041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083255

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: 2018-06-29

Devices Manufactured by RAPID Biomedical GmbH

• 04260487680539 - Na-140-Flex Coil: 2020-12-23 Na-140-Flex Coil
• 04260487680546 - C-140-Flex Coil: 2020-12-23 C-140-Flex Coil
• 04260487680232 - 1.5T Endorectal Coil: 2020-03-17 1.5T Endorectal Coil (P-Port)
• 04260487680249 - 3.0T Endorectal Coil: 2020-03-17 3.0T Endorectal Coil
• 04260487680416 - 1.5T Endorectal Coil: 2020-03-17 1.5T Endorectal Coil (A-Port)
• 04260487680423 - Endorectal Coil Support: 2020-03-17 ER Coil Support
• 04260487680430 - Endorectal Coil Screws Repair Kit: 2020-03-17 ER Coil Screws Repair Kit
• 04260487680447 - Endorectal Coil Holder Repair Kit: 2020-03-17 ER Coil Holder Repair Kit