Strata™

GUDID 00643169980402

KIT 45806 STRATA VARIUS

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve programmer

• Primary Device ID: 00643169980402
• NIH Device Record Key: 827ffd61-a6be-4505-b7ce-30e2a575ca25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strata™
• Version Model Number: 45806
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169980402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041992

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

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

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