Chocolate XD PTCA Balloon Catheter Hydrophilic Coated

GUDID M874CX141402520RX1

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic
Primary Device IDM874CX141402520RX1
NIH Device Record Key93d27524-0152-4c35-a0a7-3e52ae148625
Commercial Distribution StatusIn Commercial Distribution
Brand NameChocolate XD PTCA Balloon Catheter Hydrophilic Coated
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 Datetrue
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
HIBCCM874CX141402520RX1 [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 XD PTCA Balloon Catheter Hydrophilic Coated]

M874CX141403520RX1A
M874CX141403515RX1A
M874CX141403510RX1A
M874CX141403020RX1A
M874CX141403015RX1A
M874CX141403010RX1A
M874CX141402520RX1A
M874CX141402515RX1A
M874CX141402510RX1A
M874CX141402020RX1A
M874CX141402015RX1A
M874CX141402010RX1A

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