P-140-Flex Coil

GUDID 04260487680010

P-140-Flex Coil

RAPID Biomedical GmbH

MRI system coil, radio-frequency

• Primary Device ID: 04260487680010
• NIH Device Record Key: 8f1dcc2e-ab1f-4f9c-8289-da7a276c8766
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-140-Flex Coil
• Version Model Number: 4598-011-61951
• 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 Humidity: Between 18 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Humidity: Between 18 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Humidity: Between 18 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Humidity: Between 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260487680010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163661

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: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2018-04-24

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