| Primary Device ID | 00763000431303 |
| NIH Device Record Key | 6e49c1de-2e06-4c12-be75-34d393568217 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 46430 |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS MEDICAL, INC. |
| Device Count | 10 |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000431303 [Unit of Use] |
| GS1 | 20763000431307 [Primary] |
| GWM | Device, monitoring, intracranial pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-15 |
| Device Publish Date | 2021-02-07 |
| 00613994806628 | CATHETER 46419 EDM LUMBAR 80CM W/TIP |
| 00613994806611 | CATH 46420 EDM LUMBAR 80CM/OPEN TIP |
| 00613994800701 | CATH 44410 LUMBOPERITONEAL SYSTEM IMP |
| 00613994653352 | CATHETER 44406 LUMBAR OPEN TIP |
| 00613994653345 | CATHETER 44405 LUMBAR CLOSED TIP |
| 00643169073630 | NEEDLE 24043 TUOHY 14 GAUGE 9 CM |
| 00643169010369 | PLUG 9008 TUBING STANDARD |
| 20643169919789 | SHEATH 3805-015 PEELAWAY INTRO D15 5PK |
| 20643169919772 | SHEATH 3805-014 PEELAWAY INTRO D14 5PK |
| 00643169498105 | LASER 27613 EXACTA W/SCREW ASSY |
| 00643169498068 | TOOL 27826 STRATA II ADJUSTMENT |
| 00643169497641 | TOOL 45402 SNAP ASSEMBLY |
| 20643169496853 | TUBING 27756 CATHCONNECT STD BI 8CM 5PK |
| 20643169471522 | KIT 46442 EDM LUMBAR DRN CLS TIP 5PK |
| 20643169471515 | KIT 46441 EDM LUMBAR DRAINAGE 5PK |
| 00643169466715 | PLUG 9008 TUBING STANDARD |
| 00643169466708 | VAD 9019 18MM CONVERTIBLE |
| 00643169466692 | CATH 9025 VENT STD XTRA LENGTH MARK IMP |
| 00643169466685 | VENT 9032 QUICK RELEASE INTRODUCER |
| 00643169466661 | VAD 9053 12MM CONVT W/INLET CONN |
| 00643169466586 | NEEDLE 21048 BLUNT TIP 20 G |
| 00643169466166 | CONNECTOR 45105 CSF-CATH 3-WAY IMP |
| 20643169466146 | KIT 46141 EDM VEN DRAINAGE 5PK |
| 20643169466122 | KIT 46440 EDM LUMBAR DRAINAGE 5PK |
| 00643169213852 | LASER 27613 EXACTA W/SCREW ASSY |
| 00673978249803 | CONNECTOR 9041 LUERLOCK TO FIT 1.3MM ID |
| 00673978245140 | NEEDLE 27186 TUOHY 14-GAUGE 12CM |
| 00673978228938 | CATHETER 46418 EDM LUMBAR 24CM OPEN |
| 00673978228556 | TOOL 45402 SNAP ASSEMBLY |
| 00763000028428 | VALVE 42324 CONTOURED REG MED PRESS IMP |
| 00763000028282 | CATHETER 43555 PERITONEAL SMALL LUMEN |
| 00763000027728 | CATH 46118 EDM VENT 35CM W/TROCAR |
| 00763000027308 | CATH 27211 VENT SLOTTED 16CM |
| 00763000027278 | CATH 46420 EDM LUMBAR 80CM/OPEN TIP |
| 00763000181604 | CATH 27703 EDM NUM LENGTH MARK 35CM |
| 00763000181611 | CATH 26020 EDM VENT 2.6X4.9 TRANSLUC |
| 00763000028435 | VALVE 42322 CONTOURED REG LOW PRESS IMP |
| 00763000028411 | VALVE 42326 CONT HIGH PRESS IMP |
| 00763000028022 | VALVE 42312 SM CONTOURED LOW PRES IMP |
| 00763000028015 | VALVE 42314 SM CONTOURED MED PRESS IMP |
| 00763000031275 | NEEDLE 27186 TUOHY 14-GAUGE 12CM |
| 00763000030902 | RESVR 24084 12MM W INLET AND OUTLET CONN |
| 00763000030896 | DOME 24085 SNAP VENTRIC W/15CM TUBE |
| 00763000030834 | CONNECTOR 25027 STRT STAINLESS STEEL IMP |
| 00763000030827 | TAB 25077 FIXATION L-P |
| 00763000030780 | VAD 27051 6MM BH UNITIZED CONV. |
| 00763000030773 | VALVE 27102 CONTOURED SML LOW LOW |
| 00763000030766 | BASE 27106 SNAP ASSY W/LARGER ID |
| 00763000030674 | TOOL 45402 SNAP ASSEMBLY |
| 00763000030490 | RESERVOIR 21000 A BURR HOLE 12MM IMP |