PhenomTM 21 Catheter

GUDID 00763000399689

CATHETER FG13150-0615-2S V06 US

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00763000399689
NIH Device Record Key6a31d86c-ad15-4868-ad8f-4b1b437512dd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhenomTM 21 Catheter
Version Model NumberFG13150-0615-2S
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000399689 [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 21 Catheter]

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

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