Micro14 MicroCross Catheter, CE

GUDID B094RCX00140

ROXWOOD MEDICAL, INC.

Vascular microcatheter Vascular microcatheter
Primary Device IDB094RCX00140
NIH Device Record Keyc2ad41d9-f698-4e67-b712-21923caea5a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicro14 MicroCross Catheter, CE
Version Model NumberRCX-0014
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
HIBCCB094RCX00140 [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 Number3
Public Version Date2019-03-21
Device Publish Date2017-08-09

Devices Manufactured by ROXWOOD MEDICAL, INC.

00858480007008 - CenterCross Catheter2020-03-31
00858480007015 - Micro14 MicroCross Catheter2020-03-31
00858480007022 - Micro18 MicroCross Catheter2020-03-31
00858480007039 - Micro14es MicroCross Catheter2020-03-31
00858480007046 - MultiCross Catheter2020-03-31
00858480007053 - CenterCross Ultra Catheter2020-03-31
00858480007060 - CenterCross Ultra LV Catheter2020-03-31
00858480007077 - CenterCross Catheter,CE2020-03-31

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