Dynamic Tip™ M0046DYNTP0010

GUDID 08714729879848

Unidirectional Steerable Diagnostic Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac mapping catheter, percutaneous, single-use
Primary Device ID08714729879848
NIH Device Record Keyd9988548-0305-4d62-bae9-300e71dc6136
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynamic Tip™
Version Model NumberM0046DYNTP0010
Catalog NumberM0046DYNTP0010
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 Identifiers

Device Issuing AgencyDevice ID
GS108714729879848 [Primary]

FDA Product Code

DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-12-03
Device Publish Date2016-09-24

On-Brand Devices [Dynamic Tip™]

08714729879862Unidirectional Steerable Diagnostic Catheter
08714729879855Unidirectional Steerable Diagnostic Catheter
08714729879848Unidirectional Steerable Diagnostic Catheter
08714729877486Unidirectional Steerable Diagnostic Catheter
08714729877479Unidirectional Steerable Diagnostic Catheter

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.