PhenomTM 21 Catheter

GUDID 00763000399696

CATHETER FG13160-0615-1S V06 US

Micro Therapeutics, Inc.

Vascular microcatheter

• Primary Device ID: 00763000399696
• NIH Device Record Key: 65d77f54-ac5d-4094-a9c7-e1a0ac8edbe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PhenomTM 21 Catheter
• Version Model Number: FG13160-0615-1S
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000399696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210230

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: 2021-05-04
• Device Publish Date: 2021-04-26

On-Brand Devices [PhenomTM 21 Catheter]

• 00847536041844: CATHETER FG13160-0615-1S V04
• 00847536041837: CATHETER FG13150-1015-2S V04
• 00847536041820: CATHETER FG13150-0615-2X V04
• 00847536041813: CATHETER FG13150-0615-2S V04
• 00847536041806: CATHETER FG13150-0615-2R V04
• 00847536041790: CATHETER FG13150-0615-2J V04
• 00763000399696: CATHETER FG13160-0615-1S V06 US
• 00763000399689: CATHETER FG13150-0615-2S V06 US