PhenomTM Plus Catheter

GUDID 00847536041929

CATHETER FG19120-1015-1S V04

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00847536041929
• NIH Device Record Key: 71a4b2d2-e1e2-4df7-93c5-e6199e8b0a67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhenomTM Plus Catheter
• Version Model Number: FG19120-1015-1S
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536041929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151638

FDA Product Code

• KRA: Catheter, continuous flush

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: 2019-04-30
• Device Publish Date: 2019-04-22

On-Brand Devices [PhenomTM Plus Catheter]

• 00847536041950: CATHETER FG19135-1030-1S V04
• 00847536041943: CATHETER FG19135-0615-1S V04
• 00847536041936: CATHETER FG19120-1030-1S V04
• 00847536041929: CATHETER FG19120-1015-1S V04
• 00847536041912: CATHETER FG19120-0630-1S V04
• 00847536041905: CATHETER FG19105-0630-1S V04
• 00847536041899: CATHETER FG19105-0615-1S V04
• 00763000399733: CATHETER FG19120-1030-1S V06 US