PhenomTM 17 Catheter

GUDID 00847536041721

CATHETER FG11150-0615-2S V04

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00847536041721
• NIH Device Record Key: cb8e2728-359e-40e3-b9c3-ad9150fbf1b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhenomTM 17 Catheter
• Version Model Number: FG11150-0615-2S
• 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	00847536041721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151638

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

On-Brand Devices [PhenomTM 17 Catheter]

• 00847536041783: CATHETER FG11160-0615-2X V04
• 00847536041776: CATHETER FG11160-0615-2S V04
• 00847536041769: CATHETER FG11160-0615-2R V04
• 00847536041752: CATHETER FG11160-0615-2J V04
• 00847536041745: CATHETER FG11160-0615-1S V04
• 00847536041738: CATHETER FG11150-0615-2X V04
• 00847536041721: CATHETER FG11150-0615-2S V04
• 00847536041714: CATHETER FG11150-0615-2R V04
• 00847536041707: CATHETER FG11150-0615-2J V04
• 00763000399672: CATHETER FG11150-0615-2X V06 US
• 00763000399665: CATHETER FG11150-0615-2S V06 US
• 00763000399658: CATHETER FG11150-0615-2R V06 US
• 00763000399641: CATHETER FG11150-0615-2J V06 US