Flagship HS 1804-000-011

GUDID 10816349010962

BRIVANT LIMITED

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID10816349010962
NIH Device Record Key91f45301-c4dc-4dbf-ab57-3322355c0550
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlagship HS
Version Model NumberFSHP HS-12,S,HY,RDG/WDG195-014
Catalog Number1804-000-011
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
GS100816349010965 [Primary]
GS110816349010962 [Package]
Contains: 00816349010965
Package: Inner Carton [5 Units]
In Commercial Distribution

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-05-05

On-Brand Devices [Flagship HS ]

10816349010993FSHP HS-9,NOR,S,HY,RDG 195-014
10816349010986FSHP HS-6,NOR,J,HY,RDG 195-014
10816349010979FSHP HS-3,NOR,S,HY,RDG 195-014
10816349010962FSHP HS-12,S,HY,RDG/WDG195-014
10816349010955FSHP HS-9,S,HY,RDG,WDG 195-014

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