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 |
|---|
| KXH | Cradle, Patient, Radiologic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KXH | Cradle, Patient, Radiologic | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850043319153 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850043319153 | 00850043319153 | 850043319153 | 0850043319153 |
GMDN Terms
| 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 | Catalog | Published |
|---|
| 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 |
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