| Primary Device ID | 09421902825880 |
| NIH Device Record Key | 4267ad8a-796b-482b-a085-36715dbd0ecd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IR Shield |
| Version Model Number | AM0500 |
| Catalog Number | AM0500 |
| Company DUNS | 592534619 |
| Company Name | ADEPT MEDICAL LIMITED |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421902825880 [Primary] |
| IWX | Barrier, Control Panel, X-Ray, Movable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-09-12 |
| Device Publish Date | 2017-11-24 |
| 09421902825491 - Adept Medical Femoral Table | 2025-09-12 Surgical Support Furniture |
| 09421902825880 - IR Shield | 2025-09-12Scatter Radiation Protection Shield |
| 09421902825880 - IR Shield | 2025-09-12 Scatter Radiation Protection Shield |
| 09421902825941 - Adept Medical Drape Support | 2025-09-12 Table Accessory to support drape over patient |
| 09421905187749 - Adept Medical Retrograde IR Platform - Narrow | 2025-03-31 Support Furniture |
| 09421905187756 - Adept Medical Overhead Arm Support MR Safe - Small | 2025-03-28 To support the patient’s arms overhead with controlled shoulder flexion for imaging. |
| 09421905187763 - Adept Medical Head Immobiliser Forehead Strap | 2025-02-20 Head Immobiliser Forehead Strap |
| 09421905187725 - Adept Medical Overhead Arm Support MR Safe | 2024-08-20 To Support the patient's arms overhead with controller shoulder flexion for imaging. Intended for bores 70cm and upwards |
| 09421905187732 - Adept Medical Head Immobiliser | 2024-08-20 Head Immobiliser |