| Primary Device ID | 00763000467395 |
| NIH Device Record Key | fa7e8fd1-a707-4a85-ad2e-301c04ecea7c |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 46141 |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS MEDICAL, INC. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 00763000467395 [Unit of Use] |
| GS1 | 20763000467399 [Primary] |
| GWN | NYSTAGMOGRAPH |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-05 |
| Device Publish Date | 2024-02-26 |
| 00763000413255 - Exacta™ | 2025-02-10 ASSY 46711 EXACTA POLE CLAMP W/LASER |
| 00763000413262 - Exacta™ | 2025-02-10 CLAMP 46715 EXACTA PL NEG 25CM W/LSR |
| 00763000422653 - Valve, StrataMR II, Regular | 2025-01-31 ASSY 46965MR SHUNT STRATAMR II REG CE |
| 00763000422677 - Snap Shunt Assembly, StrataMR II, Regular | 2025-01-31 SHUNT 46966MR SNP ASSY STRATAMRII REG CE |
| 00763000422691 - Unassembled Shunt Kit, StrataMR II, Regular | 2025-01-31 KIT 46967MR UNASSY SHNT SMR II REG CE |
| 00763000422738 - StrataMR II | 2025-01-15 ASSY 46965MR SHUNT STRATAMR II REGULAR |
| 00763000422752 - StrataMR II | 2025-01-15 SHUNT 46966MR SNP ASSY STRATAMR II REG |
| 00763000422776 - StrataMR II | 2025-01-15 KIT 46967MR UNASSY SHNT STRATAMR II REG |