Flagship SB 1702-104-010

GUDID 10816349010948

BRIVANT LIMITED

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID10816349010948
NIH Device Record Keye98d30f3-efb0-49b0-925f-ba6008d1bd8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlagship SB
Version Model NumberFSHP SB GPS, J4, HY 195-014
Catalog Number1702-104-010
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
GS100816349010941 [Primary]
GS110816349010948 [Package]
Contains: 00816349010941
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 SB ]

10816349010948FSHP SB GPS, J4, HY 195-014
10816349010931FSHP SB GPS, MED,J6,HY 195-014
10816349010924FSHP SB GPS,FLPY,J4,HY 195-014

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