STRATA®

GUDID 00643169692701

VALVE 42965 FP-STRATAMR REGULAR

MEDTRONIC PS MEDICAL, INC.

Ventriculo-peritoneal/atrial shunt valve

• Primary Device ID: 00643169692701
• NIH Device Record Key: 47e57a18-5a42-442b-b480-04e5f91636f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRATA®
• Version Model Number: 42965
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169692701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152700

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-17

On-Brand Devices [STRATA®]

• 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