PhenomTM Plus Catheter

GUDID 00763000399733

CATHETER FG19120-1030-1S 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 ID00763000399733
NIH Device Record Key39571056-a4eb-40d9-aa60-7ce5b7b12b24
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhenomTM Plus Catheter
Version Model NumberFG19120-1030-1S
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
GS100763000399733 [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 Plus Catheter]

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

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