| Primary Device ID | 07640178062160 |
| NIH Device Record Key | 7ae1b5bc-9a27-4301-a04c-f03e44911bae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MR Safety Pad |
| Version Model Number | ProFoam MR Safety Angel Pad |
| Catalog Number | 1301 |
| Company DUNS | 480151859 |
| Company Name | Pearl Technology AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07640178062160 [Primary] |
| KXH | Cradle, Patient, Radiologic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-05 |
| Device Publish Date | 2025-07-28 |
| 07640178061811 - pearltec | 2025-08-05 Patient positioning aid for MR and CT imaging. |
| 07640178062078 - pearltec | 2025-08-05 Positioning aid for infants (5-9kg) during MRI and CT. |
| 07640178062160 - MR Safety Pad | 2025-08-05Positioning aid to prevent direct gantry contact in MRI |
| 07640178062160 - MR Safety Pad | 2025-08-05 Positioning aid to prevent direct gantry contact in MRI |
| 07640178062177 - pearltec | 2025-08-05 Short-term patient positioning and stabilization device during invasive and non-invasive procedures to be used on intact patient |
| 07640178061477 - Cover Multipad | 2022-05-20 Sanitary Cover to use with short-term patient positioning and stabilization device for MR and CT imaging. |
| 07640178060012 - Crania Adult | 2022-05-19 Head positioning aid for MR imaging. |
| 07640178060029 - Crania Child | 2022-05-19 Head positioning aid for MR imaging. |
| 07640178060036 - Multipad Standard | 2022-05-19 Universal patient positioning aid for MR and CT imaging. |