Chocolate XD PTCA Balloon Catheter NHC CD141403010RX

GUDID M874CD141403010RX1

Chocolate XD PTCA Balloon Catheter NHC

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic
Primary Device IDM874CD141403010RX1
NIH Device Record Keyf901b77e-1ada-4e74-bc13-003520621dde
Commercial Distribution StatusIn Commercial Distribution
Brand NameChocolate XD PTCA Balloon Catheter NHC
Version Model NumberA
Catalog NumberCD141403010RX
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
HIBCCM874CD141403010RX1 [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 Date2018-02-05

On-Brand Devices [Chocolate XD PTCA Balloon Catheter NHC]

M874CD141403520RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141403515RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141403510RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141403020RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141403015RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141403010RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141402520RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141402515RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141402510RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141402020RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141402015RX1Chocolate XD PTCA Balloon Catheter NHC
M874CD141402010RX1Chocolate XD PTCA Balloon Catheter NHC

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