Sinutwist 901059-05

GUDID 00816349011665

BRIVANT LIMITED

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00816349011665
NIH Device Record Key15382e5d-16c5-4d8e-a1b9-265e186d69c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSinutwist
Version Model NumberSINUTWIST GW, DS-J, J 190-014
Catalog Number901059-05
Company DUNS985303473
Company NameBRIVANT LIMITED
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816349011665 [Primary]

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-02
Device Publish Date2018-02-28

On-Brand Devices [Sinutwist]

00816349011672SINUTWIST GW, EDS-J, J 190-014
00816349011665SINUTWIST GW, DS-J, J 190-014
00816349011658SINUTWIST GW, ES-J, J 190-014
00816349011641SINUTWIST GW, EDS, S 190-014
00816349011634SINUTWIST GW, DS, S 190-014
00816349011627SINUTWIST GW, ES, S 190-014

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