Strata II Adjustment Kit

GUDID 00763000281274

KIT 45805 FP STRATA 2 ADJUSTMENT

MEDTRONIC PS MEDICAL, INC.

Cerebrospinal fluid shunt valve programmer

• Primary Device ID: 00763000281274
• NIH Device Record Key: 6c21061b-f987-4e78-ae33-2902c96ec67c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strata II Adjustment Kit
• Version Model Number: 45805
• 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: 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000281274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060681

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-09
• Device Publish Date: 2022-12-01

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

• 00763000281243 - Exacta Pole Clamp with laser level: 2025-02-25 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00763000281229 - Exacta Pole Clamp with laser level: 2025-02-24 ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00763000413255 - Exacta™: 2025-02-10 ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00763000413262 - Exacta™: 2025-02-10 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00763000422653 - Valve, StrataMR II, Regular: 2025-01-31 ASSY 46965MR SHUNT STRATAMR II REG CE
• 00763000422677 - Snap Shunt Assembly, StrataMR II, Regular: 2025-01-31 SHUNT 46966MR SNP ASSY STRATAMRII REG CE
• 00763000422691 - Unassembled Shunt Kit, StrataMR II, Regular: 2025-01-31 KIT 46967MR UNASSY SHNT SMR II REG CE
• 00763000422738 - StrataMR II: 2025-01-15 ASSY 46965MR SHUNT STRATAMR II REGULAR