| 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 |
| 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 |
| 00763000333461 - Exacta™ | 2024-12-23 EDMS 27579 EXACTA W/ PATIENT LINE Y-PORT |
| 00763000333478 - Exacta™ | 2024-12-23 KIT 27581 EXACTA W/EDM VCATH 35CM |
| 00763000333492 - Exacta™ | 2024-12-23 EDM 27636 EXACTA W/BRAIDED CORD LOCK |
| 00763000333508 - Exacta™ | 2024-12-23 BAG 27654 EXACTA W/DRAINPORT GLUED ON |
| 00763000333515 - Exacta™ | 2024-12-23 EDM 27666 EXCTA W GLUE STPCK GR PT LN |