Primary Device ID | 00763000030117 |
NIH Device Record Key | 5d57fda0-c190-46ea-889a-8672ee4c984b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Strata® |
Version Model Number | 27739 |
Company DUNS | 089055867 |
Company Name | MEDTRONIC PS MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000030117 [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 | 2020-04-27 |
Device Publish Date | 2020-04-19 |
00613994946461 | VALVE 27932 STRATA NSC SML EXTRACTED |
00613994804648 | VALVE 42866 FP-STRATA 2 REGULAR |
00613994804631 | VALVE 42856 FP-STRATA 2 SMALL |
00613994721648 | SHUNT 27925 STRATA NSC SML W/INTEG V/RES |
00613994721631 | SHUNT 27924 STRATA NSC REG W/INTG V/RES |
00613994721624 | SHUNT 27923 STRATA II SML W/INTEG V/RES |
00613994721617 | SHUNT 27922 STRATA II REG W/INTEG V/RES |
00613994556554 | ASSY 27903 STRATA II SM CP CATHETER |
00613994380128 | SHUNT 46635 STRATA NSC BURR HOLE |
00613994380111 | SHUNT 46836 STRATA II BURR HOLE |
00613994380104 | VALVE 42335 STRATA NSC BURR HOLE |
00613994380098 | VALVE 42836 STRATA II BURR HOLE |
00613994346889 | SHNT 27888 STRATA II SNAP ASSY REG PCATH |
00613994128584 | SHUNT 27864 STRATA II REGULAR 120CM |
00643169011137 | SHUNT 27814 STRATA II ASSY SML |
00643169011120 | SHUNT 27815 STRATA II ASSY REG |
00643169010826 | VALVE 27827 STRATA II REG EXTRACTED |
00643169010819 | VALVE 42355 FP STRATA NSC SMALL |
00643169010796 | SHUNT 44420 STRATA KIT NSC LP |
00643169010789 | KIT 44421 STRATA NSC LP OPEN LUMBAR |
00643169010772 | SHUNT 44430 STRATA KIT NSC LP ASSY |
00643169010765 | VALVE 44465 STRATA NSC LP |
00643169010710 | ASSY 46655 FP SHUNT STRATA NSC SMALL |
00643169010697 | ASSY 46856 FP-STRATA 2 SHUNT SML |
00643169010680 | ASSY 46866 FP-STRATA 2 SHUNT REG |
00643169010673 | SHUNT 46871 FP-STRATA UNI SML 8 |
00643169010666 | UNISHUNT 46876 FP STRATA SM 11.5 |
00643169010659 | SHUNT 46881 FP-STRATA UNI REG 11 |
00643169010642 | SHUNT 46886 FP-STRATA UNI REG 13.5 |
00643169010536 | VALVE 27812 STRATA II SM EXTRACTED |
00643169010529 | SHUNT 27816 SNAP STRATA II SMALL |
00643169010512 | SHUNT 27817 SNAP STRATA II REG |
00643169010482 | KIT 27820 UNI STRATA II SM V 11 PCATH90 |
00643169010475 | KIT 27821 UNI STRATA II REG V13 PCATH90 |
00643169010444 | SHUNT 27824 UNI STRATA II SM BIO |
00643169990883 | KIT 45805 FP STRATA 2 ADJUSTMENT |
00643169692886 | SET ADJUST 45905 STRATAMR MAGNET |
00643169692718 | VALVE 42955 FP-STRATAMR SMALL |
00643169692701 | VALVE 42965 FP-STRATAMR REGULAR |
00643169497634 | KIT 45805 FP STRATA 2 ADJUSTMENT |
00643169497627 | KIT 45806 STRATA VARIUS |
00643169497610 | TOOL 45809 STRATAVARIUS ADJUSTMENT |
00643169497016 | ASSY 46655 FP SHUNT STRATA NSC SMALL |
00643169496989 | ASSY 46665 FP SHUNT STRATA NSC REG |
00643169496873 | SHUNT 27739 STRATA NSC SNAP SML 120CM |
00643169496866 | SHUNT 27740 STRATA NSC SNAP REG 120CM |
00643169466920 | VALVE 42355 FP STRATA NSC SMALL |
00643169466210 | VALVE 44465 STRATA NSC LP |
00643169466111 | VALVE 42365 FP STRATA NSC REGULAR |
00763000027261 | VALVE 42866 FP-STRATA 2 REGULAR |
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QUALITY PLUS MANUFACTURING, LLC 2023-11-20 |
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inMusic Brands, Inc. 2023-11-13 |
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Vornado Air, LLC 2023-06-21 |
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Metal Tiger plc 2023-04-21 |
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Strata Garments, LLC 2023-02-27 |
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StrataPT, LLC 2023-02-14 |
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Metal Tiger plc 2022-12-02 |
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Pinnacle 360 Hoover, LLC 2022-08-24 |