MultiCross Catheter, CE

GUDID B094MCX01000

ROXWOOD MEDICAL, INC.

Blunt-microdissection atherectomy catheter
Primary Device IDB094MCX01000
NIH Device Record Key378d04b9-05f7-48cc-875e-56461bc6df7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMultiCross Catheter, CE
Version Model NumberMCX-0100
Company DUNS055819211
Company NameROXWOOD MEDICAL, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB094MCX01000 [Primary]

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-09

On-Brand Devices [MultiCross Catheter, CE]

00858480007084MCX-0100
B094MCX01000MCX-0100

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