PhenomTM 17 Catheter

GUDID 00763000399672

CATHETER FG11150-0615-2X V06 US

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use
Primary Device ID00763000399672
NIH Device Record Key3f2f180d-4772-48b5-a147-80a0cb984e1d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhenomTM 17 Catheter
Version Model NumberFG11150-0615-2X
Company DUNS826110710
Company NameMicro Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000399672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, continuous flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [PhenomTM 17 Catheter]

00847536041783CATHETER FG11160-0615-2X V04
00847536041776CATHETER FG11160-0615-2S V04
00847536041769CATHETER FG11160-0615-2R V04
00847536041752CATHETER FG11160-0615-2J V04
00847536041745CATHETER FG11160-0615-1S V04
00847536041738CATHETER FG11150-0615-2X V04
00847536041721CATHETER FG11150-0615-2S V04
00847536041714CATHETER FG11150-0615-2R V04
00847536041707CATHETER FG11150-0615-2J V04
00763000399672CATHETER FG11150-0615-2X V06 US
00763000399665CATHETER FG11150-0615-2S V06 US
00763000399658CATHETER FG11150-0615-2R V06 US
00763000399641CATHETER FG11150-0615-2J V06 US
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.