Flexiva TracTip

GUDID 08714729808176

Water 50W Max / Air 8W Max

BOSTON SCIENTIFIC CORPORATION

General/multiple surgical laser system beam guide, single-use
Primary Device ID08714729808176
NIH Device Record Key13ac972d-7dd3-4262-b753-0d2e3706e32c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexiva TracTip
Version Model NumberM0068403960
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729808169 [Primary]
GS108714729808176 [Package]
Contains: 08714729808169
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 Number5
Public Version Date2021-04-07
Device Publish Date2016-09-24

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08714729780489 - Blazer™ Dx-202026-01-21 Bidirectional Steerable Diagnostic Catheter
08714729780496 - Blazer™ Dx-202026-01-21 Bidirectional Steerable Diagnostic Catheter

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