| Primary Device ID | 00763000422660 |
| NIH Device Record Key | 5e21d3ef-ca3b-439a-8544-051579ee2efc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StrataMR II |
| Version Model Number | 46956MR |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS MEDICAL, INC. |
| Device Count | 1 |
| 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 | 00763000422660 [Primary] |
| JXG | Shunt, central nervous system and components |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-12 |
| Device Publish Date | 2025-05-02 |
| 00763000422639 | VALVE 42965MR STRATAMR II REGULAR CE |
| 00763000422622 | VALVE 42955MR STRATAMR II SMALL CE |
| 00763000422776 | KIT 46967MR UNASSY SHNT STRATAMR II REG |
| 00763000422752 | SHUNT 46966MR SNP ASSY STRATAMR II REG |
| 00763000422738 | ASSY 46965MR SHUNT STRATAMR II REGULAR |
| 00763000422660 | SHUNT 46956MR SNP ASSY STRATAMRII SM CE |