AcQGuide 122852

GUDID 00857042007456

AcQGuide Flex 65 cm Med Curl with AcQCross QX

ACUTUS MEDICAL, INC.

Vascular guide-catheter, single-use
Primary Device ID00857042007456
NIH Device Record Key0d15a4c6-71eb-4848-a9ae-3534f9e0c51b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcQGuide
Version Model Number122852
Catalog Number122852
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 Datefalse
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
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
GS100857042007456 [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 Date2019-08-01
Device Publish Date2019-07-24

On-Brand Devices [AcQGuide]

00857042007012AcQGuide® Steerable Sheath
00857042007456AcQGuide Flex 65 cm Med Curl with AcQCross QX
00857042007432AcQGuide Mini 65cm - L2 with AcQCross QX

Trademark Results [AcQGuide]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACQGUIDE
ACQGUIDE
87246283 5308281 Live/Registered
Acutus Medical, Inc.
2016-11-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.