MicroCross 14 Catheter, 135cm, CE

GUDID 00858480007152

ROXWOOD MEDICAL, INC.

Vascular microcatheter
Primary Device ID00858480007152
NIH Device Record Key18191ea0-1118-4009-87bf-e7ca7ec7f320
Commercial Distribution Discontinuation2020-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMicroCross 14 Catheter, 135cm, CE
Version Model NumberRCX-2014
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
GS100858480007152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-31
Device Publish Date2018-09-20

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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