Home GUDID 00850043319153 Hyperfine Foam Back Pad
Primary DI 00850043319153
Brand Hyperfine Foam Back Pad
Company Hyperfine Operations, Inc.
Model V2
Catalog number 204-00081-01
Device description Foam cushion used as a support device to aid in patient comfort and positioning during an MRI procedure.
Published 2026-05-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KXH Cradle, Patient, Radiologic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KXH Cradle, Patient, Radiologic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850043319153 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850043319153 00850043319153 850043319153 0850043319153
GMDN Terms# Term, Definition table Term Definition Radiological general body-part positioner A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
Regulatory Flags# DUNS number 051795046 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850043319146 Head Stabilizer 900-11022-00 2024-12-11 00850043319160 Swoop Portable MR Imaging Scanner v2.2 900-11050-02 2025-12-04 00850043319184 Swoop Transmit and Receive Radio Frequency Head Coil v2.2 900-11015-01 2025-12-04 00850043319047 Hyperfine Foam Head Pad 810-11108-00 2023-01-25 00850043319023 Swoop Transmit and Receive Radio Frequency Head Coil 900-11011-06 2023-02-16 00850043319009 Swoop Portable MRI Scanner 850-11001-06 2023-02-15 00860000606165 Swoop Transmit and Receive Radio Frequency Head Coil 850-11016-05 2021-07-26 00860000606172 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner 850-11001-05 2021-07-26 00860000606189 BrainInsight Version 1.0 2021-03-05 00860000606134 Swoop Site Quality Assurance Phantom V1.0 (810-11049-01) 2020-09-16 00860000606141 Swoop Point-of-Care Magnetic Resonance Imaging Scanner V1.7 (850-11001-04) 2020-09-16 00860000606158 Swoop Transmit and Receive Radio Frequency Head Coil V2.0 (815-11016-04) 2020-09-16
Other Devices Sharing Product Codes#