MaxForce TTS

GUDID 08714729099598

High Performance Balloon Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter, non-medicated
Primary Device ID08714729099598
NIH Device Record Keya5bb575d-3a5c-4a24-ad15-11032a132586
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxForce TTS
Version Model NumberM00589080
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Identifiers

Device Issuing AgencyDevice ID
GS108714729099598 [Primary]

FDA Product Code

KNQDilator, esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-12-23
Device Publish Date2016-09-24

On-Brand Devices [MaxForce TTS]

08714729099925High Performance Balloon Dilatation Catheter
08714729099918High Performance Balloon Dilatation Catheter
08714729099901High Performance Balloon Dilatation Catheter
08714729099895High Performance Balloon Dilatation Catheter
08714729099598High Performance Balloon Dilatation Catheter
08714729099581High Performance Balloon Dilatation Catheter
08714729080619High Performance Balloon Dilatation Catheter
08714729080602High Performance Balloon Dilatation Catheter

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