Hyperfine Foam Head Pad

GUDID 00850043319047

Memory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure.

Hyperfine Operations, Inc.

Radiological headrest

• Primary Device ID: 00850043319047
• NIH Device Record Key: 63d7722e-79dc-4816-ab2e-6bfa966fe391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyperfine Foam Head Pad
• Version Model Number: 810-11108-00
• Company DUNS: 051795046
• Company Name: Hyperfine Operations, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00850043319047 [Primary]

FDA Product Code

• IWY: Holder, Head, Radiographic

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: 2025-03-13
• Device Publish Date: 2023-01-25