NiA

GUDID 20643169919765

SHEATH 3805-012 PEELAWAY INTRO D12 5PK

MEDTRONIC PS MEDICAL, INC.

Wire/ligature passer, reusable

• Primary Device ID: 20643169919765
• NIH Device Record Key: 981553a1-7128-4b45-82c0-d3cedb6c3cff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NiA
• Version Model Number: 3805-012
• 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: 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: 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
• 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	00643169919761 [Primary]
GS1	20643169919765 [Package]; Contains: 00643169919761; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990333

FDA Product Code

• GWG: Endoscope, neurological

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: 2018-07-24
• Device Publish Date: 2018-04-20

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

• 00763000422660 - StrataMR II: 2025-05-12 SHUNT 46956MR SNP ASSY STRATAMRII SM CE
• 00763000950941 - Duet EDMS: 2025-03-31 EDMS 46913 DUET INTERLINK SITES/US
• 00763000950972 - Duet EDMS: 2025-03-31 EDMS 46914 DUET BLUECORE SITES/US
• 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