CenterCross Ultra LV Catheter

GUDID B094LV01000

The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vascula

ROXWOOD MEDICAL, INC.

Blunt-microdissection atherectomy catheter
Primary Device IDB094LV01000
NIH Device Record Keyc68d0e6b-e5d6-4e84-8e22-8faf936bfd9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenterCross Ultra LV Catheter
Version Model NumberLV-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
HIBCCB094LV01000 [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 Date2017-04-19

On-Brand Devices [CenterCross Ultra LV Catheter]

00858480007060LV-0100
B094LV01000The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewire

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