Flexiva™ ID TracTip

GUDID 08714729963844

High Power Single-Use Laser Fiber

BOSTON SCIENTIFIC CORPORATION

General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use
Primary Device ID08714729963844
NIH Device Record Key191e68c1-ec8c-4aef-8643-b04fb9c6bc90
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiva™ ID TracTip
Version Model NumberM006R8403960
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729963837 [Primary]
GS108714729963844 [Package]
Contains: 08714729963837
Package: [5 Units]
In Commercial Distribution

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-07
Device Publish Date2017-10-21

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

00191506034429 - RHYTHMIA HDx™2024-03-11 Ablation Connection Box
00191506020408 - IntellaNav StablePoint™ Cable2024-03-08 Catheter Cable
08714729419396 - Percuflex™2024-03-08 Ureteral Stent
08714729992233 - INTELLANAV STABLEPOINT™2024-03-08 Ablation Catheter
08714729992240 - INTELLANAV STABLEPOINT™2024-03-08 Ablation Catheter
00191506019570 - Rubicon™ Control2024-02-26 Support Catheter
00191506019594 - Rubicon™ Control2024-02-26 Support Catheter
00191506019617 - Rubicon™ Control2024-02-26 Support Catheter

Trademark Results [Flexiva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEXIVA
FLEXIVA
85114331 4029813 Live/Registered
Boston Scientific Scimed, Inc.
2010-08-24

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