Chocolate PTCA BAlloon Catheter

GUDID M874CH141403010RX1

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic
Primary Device IDM874CH141403010RX1
NIH Device Record Key310a4ca5-05db-4c89-90ce-04b6682c1207
Commercial Distribution StatusIn Commercial Distribution
Brand NameChocolate PTCA BAlloon Catheter
Version Model NumberA
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
HIBCCM874CH141403010RX1 [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 [Chocolate PTCA BAlloon Catheter]

M874CH141403520RX1A
M874CH141403515RX1A
M874CH141403510RX1A
M874CH141403020RX1A
M874CH141403015RX1A
M874CH141403010RX1A
M874CH141402520RX1A
M874CH141402515RX1A
M874CH141402510RX1A
M874CH141402020RX1A
M874CH141402015RX1A
M874CH141402010RX1A

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