GUDID 20643169115952

INTRDCR 208223 10PK 8F 23CM INPUT OBT

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20643169115952
• NIH Device Record Key: 61d8dc42-cc8f-4839-8a9b-b8210a254db7
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 208223
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 23 Centimeter
• Length: 23 Centimeter
• Length: 23 Centimeter
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter
• Catheter Gauge: 8 French
• Length: 23 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169115958 [Primary]
GS1	20643169115952 [Package]; Contains: 00643169115958; Package: PK [10 Units]; Discontinued: 2018-10-05; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132617

FDA Product Code

• DYB: INTRODUCER, 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: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-02-03

Devices Manufactured by MEDTRONIC, INC.

• 00763000300623 - N/A: 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM
• 00763000596958 - InterStim™ SureScan™: 2026-01-08 LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL
• 00763000596996 - InterStim™ SureScan™: 2026-01-08 LEAD 978B141 ISTM SSMRI 4.32MM EMAN GLBL
• 00763000994198 - N/A: 2026-01-07 ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR
• 00199150065684 - NA: 2026-01-06 CUSTOM PACK BB11W65R6 HLO SPECTRUM
• 00199150065691 - NA: 2026-01-06 CUSTOM PACK BB6V93R18 EVL A 3/8 E
• 00199150065745 - NA: 2026-01-06 CUSTOM PACK BB10V37R6 EVL 1/4 PED
• 20199150065763 - NA: 2026-01-06 CUSTOM PACK BB11V27R2 10PK ACC 3/8 CONN