MultiCross Catheter

GUDID B094MC01000

ROXWOOD MEDICAL, INC.

Blunt-microdissection atherectomy catheter
Primary Device IDB094MC01000
NIH Device Record Key3eae8ed6-7b23-4c2e-ba2a-ef2fa7fb89b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMultiCross Catheter
Version Model NumberMC-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
HIBCCB094MC01000 [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 Date2016-04-27

On-Brand Devices [MultiCross Catheter]

00858480007046MC-0100
B094MC01000MC-0100

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.