Telescope™

GUDID 00763000156978

GEC TELE 7F TELESCOPE US

MEDTRONIC, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00763000156978
• NIH Device Record Key: b575f678-7be5-43f0-919b-2fdf79a27ee3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Telescope™
• Version Model Number: TELE7F
• 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
• 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

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, and dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000156978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183353

FDA Product Code

• DQY: Catheter, percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-15
• Device Publish Date: 2019-04-05

On-Brand Devices [Telescope™]

• 00763000156978: GEC TELE 7F TELESCOPE US
• 00763000156954: GEC TELE 6F TELESCOPE US