16Ch Flex SPEEDER Pad Kit

GUDID 00856181003725

These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coi

NEOCOIL, LLC

MRI system coil, radio-frequency

• Primary Device ID: 00856181003725
• NIH Device Record Key: 94728d2f-dd2a-4ab3-8678-56738caf796a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16Ch Flex SPEEDER Pad Kit
• Version Model Number: 72
• Company DUNS: 781155176
• Company Name: NEOCOIL, LLC
• 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: 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	00856181003725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121362

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: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-03-16

Devices Manufactured by NEOCOIL, LLC

• 00850028932452 - 3T 16ch Breast Coil: 2023-03-31
• 00850028932469 - 1.5T 16ch Breast Coil: 2023-03-31
• 00850028932513 - Biopsy Grid Assembly, Pack, Breast Coil: 2023-03-31
• 00850028932520 - Drape Pack, Biopsy, Breast Coil: 2023-03-31
• 00856181003916 - 1.5T 16ch Shoulder Coil (Device): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover
• 00856181003947 - 3.0T 16ch Shoulder Coil (FRU): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover
• 00856181003954 - 1.5T 16ch Shoulder Coil (FRU): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover
• 00856181003961 - 16ch Shoulder Coil, Replacement Pad Kit (FRU): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover