Glider PTCA BAlloon Catheter

GUDID M8744100A25041

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic
Primary Device IDM8744100A25041
NIH Device Record Key607b7c6b-bbce-48fa-9663-3ce568a36841
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlider PTCA BAlloon Catheter
Version Model NumberB
Company DUNS623861577
Company NameTRIREME MEDICAL, LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM8744100A25041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2017-02-13

On-Brand Devices [Glider PTCA BAlloon Catheter]

M8744100A35201B
M8744100A35121B
M8744100A35081B
M8744100A35041B
M8744100A30201B
M8744100A30121B
M8744100A30081B
M8744100A30041B
M8744100A25201B
M8744100A25121B
M8744100A25081B
M8744100A25041B
M8744100A20201A
M8744100A20121A
M8744100A20081A
M8744100A20041A
M8744100A15201A
M8744100A15121A
M8744100A15081A
M8744100A15041A

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