Neck & Brachial Plexus SatPad™ Set 200018

GUDID 00850004813249

Neck & Brachial Plexus Radiological Positioning Device

Sat Pad Inc.

Radiological headrest

• Primary Device ID: 00850004813249
• NIH Device Record Key: 9403ba13-ed5e-4075-aea3-69c4ff879851
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neck & Brachial Plexus SatPad™ Set
• Version Model Number: 1
• Catalog Number: 200018
• Company DUNS: 081347868
• Company Name: Sat Pad Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 667-225-2721
• Email: pat@satpads.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004813157 [Package]; Package: carton [1 Units]; In Commercial Distribution
GS1	00850004813249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926416

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: 2019-04-12
• Device Publish Date: 2019-04-02

Devices Manufactured by Sat Pad Inc.

• 00850004813263 - Breast Pad Insert H SatPad™: 2019-12-20 Breast Pad Insert Sat Pad™ , Radiological Positioning device for MR
• 10850004813253 - Breast Pad Insert SatPad™: 2019-06-26 Breast Pad Insert Sat Pad™ , Radiological Positioning device for MR
• 00850004813027 - Ankle/Foot SatPad™: 2019-04-12 Ankle/Foot Radiological Positioning Device
• 00850004813041 - Knee SatPad™: 2019-04-12 Knee Radiological Positioning Device
• 00850004813058 - Neck SatPad™: 2019-04-12 Neck SatPad, Radiological positioning device for MR
• 00850004813072 - Ankle Toe Cap SatPad™: 2019-04-12 Ankle Toe Cap Radiological Positioning Device For MR
• 00850004813089 - Shoulder SatPad™: 2019-04-12 Shoulder Radiological Positioning Device
• 00850004813102 - Brachial Plexus SatPad™: 2019-04-12 Brachial Plexus Radiological positioning devise for MR