AcQGuide VUE 900201

GUDID 00857042007906

AcQGuide VUE Steerable Sheath

ACUTUS MEDICAL, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00857042007906
NIH Device Record Key4b85e5c9-f0a4-41cf-ba5d-573104d7c98f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcQGuide VUE
Version Model Number900201
Catalog Number900201
Company DUNS844418199
Company NameACUTUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com
Phone(442)232-6100
Emailproduct.complaints@acutus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857042007906 [Primary]

FDA Product Code

DRACatheter, Steerable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-13

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