AGILITY 614581

GUDID 10886704029106

AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 205cm 8cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Standard Contents: 1 guidewire, 1 torquing device and 1 introducer.

Medos International Sàrl

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10886704029106
• NIH Device Record Key: 3a678c01-c18f-4bbf-853d-2ce20ccbb345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILITY
• Version Model Number: 614-581
• Catalog Number: 614581
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: true
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704029106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133625

FDA Product Code

• MOF: GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-27
• Device Publish Date: 2016-06-30

On-Brand Devices [AGILITY]

• 10886704029106: AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 205cm 8cm Steerab
• 10886704029090: AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 175cm 10cm Steera
• 10886704029083: AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 175cm 8cm Steerab
• 10886704029076: AGILITY 14 STEERABLE GUIDEWIRES Guidewire Dia. .014 Inch (.36mm) Usable Length 350cm 10cm Steera
• 10886704029069: AGILITY 14 STEERABLE GUIDEWIRES Guidewire Dia. .014 Inch (.36mm) Usable Length 205cm 20cm Steera
• 10886704029052: AGILITY 14 STEERABLE GUIDEWIRES Guidewire Dia. .014 Inch (.36mm) Usable Length 205cm 10cm Steera
• 10886704029045: AGILITY 10 STEERABLE GUIDEWIRES Guidewire Dia. .010 Inch (.25mm) Usable Length 195cm 10cm Steera
• 10886704029038: AGILITY 10 STEERABLE GUIDEWIRES Guidewire Dia. .010 Inch (.25mm) Usable Length 195cm 10cm Steera