EDM

GUDID 00643169497603

CLAMP 46135 QUICK ATTACH POLE

MEDTRONIC PS MEDICAL, INC.

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• Primary Device ID: 00643169497603
• NIH Device Record Key: 8b086fe7-c2af-44a5-ad97-dee3ed282437
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDM
• Version Model Number: 46135
• 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
• 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 Dimensions

• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch
• Length: 2.98 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169497603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983799

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-11

On-Brand Devices [EDM]

• 00643169497603: CLAMP 46135 QUICK ATTACH POLE
• 00643169497078: EDM 27637 VCATH TRANS OD 4.9MM W/TROC
• 00643169496910: EDM 27659 V/CATHETER 20CM LENGTH MARKER
• 00763000030261: EDM 27637 VCATH TRANS OD 4.9MM W/TROC
• 00763000030148: EDM 27659 V/CATHETER 20CM LENGTH MARKER