GUDID 20613994618645

STYLET 629375 US DS KNOB ST

MEDTRONIC, INC.

Catheter stylet Catheter stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet

• Primary Device ID: 20613994618645
• NIH Device Record Key: 6f252939-1653-45cc-a06b-d7661fb1f414
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 629375
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter
• Outer Diameter: 0.406 Millimeter
• Length: 75 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994618641 [Primary]
GS1	20613994618645 [Package]; Contains: 00613994618641; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010906

FDA Product Code

• DRB: STYLET, CATHETER

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: 2016-04-01

Devices Manufactured by MEDTRONIC, INC.

• 00763000944322 - NA: 2024-04-23 CUSTOM PACK HY4953R31 MEMB PK
• 00763000944339 - NA: 2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK
• 00763000944346 - NA: 2024-04-23 CUSTOM PACK BB12F35R5 A PACK
• 00763000945558 - NA: 2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO
• 00763000943844 - NA: 2024-04-12 CUSTOM PACK BB11J59R5 PEDS
• 00763000943851 - NA: 2024-04-12 CUSTOM PACK BB12F35R3 A PACK
• 00763000943868 - NA: 2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
• 00763000943899 - NA: 2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD