Pruitt Aortic Occlusion Catheter 2100-12

GUDID 00840663101511

Pruitt Aortic Occlusion Catheter, 12F

LEMAITRE VASCULAR, INC.

Intravascular occluding balloon catheter, image-guided
Primary Device ID00840663101511
NIH Device Record Keyb28f0608-d845-4e9c-baa6-963aedb56582
Commercial Distribution StatusIn Commercial Distribution
Brand NamePruitt Aortic Occlusion Catheter
Version Model Number2100-12
Catalog Number2100-12
Company DUNS184805166
Company NameLEMAITRE VASCULAR, 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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx
Phone781-221-2266
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663101511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQTOccluder, Catheter Tip

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2015-06-30

On-Brand Devices [Pruitt Aortic Occlusion Catheter]

00840663101528Pruitt Aortic Occlusion Catheter, 12F, eIFU
00840663101511Pruitt Aortic Occlusion Catheter, 12F

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