| Primary Device ID | 09421901970499 |
| NIH Device Record Key | d237d9dd-3d0f-49a2-9c84-5d2500076dab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adept Medical Myringotomy Knife |
| Version Model Number | NZ3245-10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 09421901970499 [Primary] |
| JYP | Knife, Myringotomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-28 |
| Device Publish Date | 2024-03-20 |
| 09421902825491 - Adept Medical Femoral Table | 2025-09-12 Surgical Support Furniture |
| 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 |