CenterCross Catheter

GUDID B094CC01000

ROXWOOD MEDICAL, INC.

Blunt-microdissection atherectomy catheter Blunt-microdissection atherectomy catheter
Primary Device IDB094CC01000
NIH Device Record Key2682cc07-580a-4124-873d-9151dc6c78f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenterCross Catheter
Version Model NumberCC-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
HIBCCB094CC01000 [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 [CenterCross Catheter]

00858480007008CC-0100
B094CC01000CC-0100

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