AcQCross Qx 900305

GUDID 00850027837161

AcQCross Qx - MAX 70cm

ACUTUS MEDICAL, INC.

Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle Cardiac transseptal access electrosurgical dilator/needle
Primary Device ID00850027837161
NIH Device Record Key880ad66d-9319-4049-b01b-5f3387d4db1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcQCross Qx
Version Model Number900305
Catalog Number900305
Company DUNS844418199
Company NameACUTUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
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
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
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
Phone(442)232-6100
Emailproduct.complaints@acutus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850027837161 [Primary]

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-08

On-Brand Devices [AcQCross Qx]

00850027837161AcQCross Qx - MAX 70cm
00850027837147AcQCross Qx - FC 65cm
00850027837123AcQCross Qx - VZ 71cm
00850027837109AcQCross Qx - SL 63cm
00850027837086AcQCross Qx - AG 61cm
00850027837055AcQCross Qx - AG 71cm

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