Strata™

GUDID 00643169975941

SHUNT 46837 STRATA II BURR HOLE

MEDTRONIC PS MEDICAL, INC.

Ventriculo-peritoneal/atrial shunt valve Ventriculo-peritoneal/atrial shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve

• Primary Device ID: 00643169975941
• NIH Device Record Key: d2d84de4-9a06-4ec5-a436-b6aad35d71fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strata™
• Version Model Number: 46837
• 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	00643169975941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083076

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: 2017-06-12

On-Brand Devices [Strata™]

• 00643169980402: KIT 45806 STRATA VARIUS
• 00643169976061: SHUNT 96665 STRATA NSC ASSY REG BIOGLIDE
• 00643169976054: SHUNT 96655 STRATA NSC ASSY SML BIOGLIDE
• 00643169976047: VALVE 92866 FP STRATA 2 REG BG
• 00643169976030: VALVE 92856 FP STRATA 2 SML BG
• 00643169976023: VALVE 92365 STRATA NSC REG BIOGLIDE
• 00643169976016: VALVE 92355 STRATA NSC SML BIOGLIDE
• 00643169976009: SHUNT 46886 FP-STRATA UNI REG 13.5
• 00643169975996: SHUNT 46881 FP-STRATA UNI REG 11
• 00643169975989: UNISHUNT 46876 FP STRATA SM 11.5
• 00643169975972: SHUNT 46871 FP-STRATA UNI SML 8
• 00643169975965: ASSY 46866 FP-STRATA 2 SHUNT REG
• 00643169975958: ASSY 46856 FP-STRATA 2 SHUNT SML
• 00643169975941: SHUNT 46837 STRATA II BURR HOLE
• 00643169975934: ASSY 46665 FP SHUNT STRATA NSC REG
• 00643169975927: ASSY 46655 FP SHUNT STRATA NSC SMALL
• 00643169975910: SHUNT 46636 STRATA NSC BURR
• 00643169975903: KIT 45805 FP STRATA 2 ADJUSTMENT
• 00643169975897: VALVE 44465 STRATA NSC LP
• 00643169975880: SHUNT 44430 STRATA KIT NSC LP ASSY
• 00643169975873: KIT 44421 STRATA NSC LP OPEN LUMBAR
• 00643169975866: SHUNT 44420 STRATA KIT NSC LP
• 00643169975859: CATHETER 44406 LUMBAR OPEN TIP
• 00643169975842: CATHETER 44405 LUMBAR CLOSED TIP
• 00643169975835: VALVE 42866 FP-STRATA 2 REGULAR
• 00643169975828: VALVE 42856 FP-STRATA 2 SMALL
• 00643169975811: VALVE 42836 STRATA II BURR HOLE
• 00643169975804: VALVE 42365 FP STRATA NSC REGULAR
• 00643169975798: VALVE 42355 FP STRATA NSC SMALL
• 00643169975781: VALVE 42335 STRATA NSC BURR HOLE
• 00643169975774: VALVE 27932 STRATA NSC SML EXTRACTED
• 00643169975767: ASSY 27903 STRATA II SM CP CATHETER
• 00643169975750: SHNT 27888 STRATA II SNAP ASSY REG PCATH
• 00643169975743: SHUNT 27864 STRATA II REGULAR 120CM
• 00643169975736: VALVE 27832 SNAP STRATA II REG BLUNT
• 00643169975729: SHUNT 27831 SNAP STRATA II REG BLUNT P/C
• 00643169975712: VALVE 27829 STRATA II REG INLET BUTTON
• 00643169975705: VALVE 27827 STRATA II REG EXTRACTED
• 00643169975699: UNT 27825 STRATA II UNI REG BIO
• 00643169975682: SHUNT 27824 UNI STRATA II SM BIO
• 00643169975675: SHUNT 27823 STRATA II ASSY SNP REG BIO
• 00643169975668: SHUNT 27822 STRATA II SNP ASSY SM BIO
• 00643169975651: KIT 27821 UNI STRATA II REG V13 PCATH90
• 00643169975644: KIT 27820 UNI STRATA II SM V 11 PCATH90
• 00643169975637: SHUNT 27819 STRATA II REG BIO
• 00643169975620: SHUNT 27818 STRATA II SML BIO
• 00643169975613: SHUNT 27817 SNAP STRATA II REG
• 00643169975606: SHUNT 27816 SNAP STRATA II SMALL
• 00643169975590: SHUNT 27815 STRATA II ASSY REG
• 00643169975583: SHUNT 27814 STRATA II ASSY SML