FDA.reportPublic FDA data

CenterCross Ultra Catheter, CE

Primary DI
B094UCX01000
Brand
CenterCross Ultra Catheter, CE
Company
ROXWOOD MEDICAL, INC.
Model
UCX-0100
Published
2017-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B094UCX01000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blunt-microdissection atherectomy catheterA manually-powered instrument intended to be used to create a pathway through an occluded blood vessel to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [especially a chronic total occlusion (CTO) of a coronary artery], prior to further percutaneous intervention to remove the lesion. It typically consists of a long, thin, flexible segment, introduced into the vasculature, that is equipped to mechanically disrupt the lesion (e.g., by blunt microdissection) through manipulation of hand controls at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055819211
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B094CC01000CenterCross CatheterCC-01002016-04-27
B094CCX01000CenterCross Catheter, CECCX-01002017-08-09
B094LV01000CenterCross Ultra LV CatheterLV-01002017-04-19
B094MC01000MultiCross CatheterMC-01002016-04-27
B094MCX01000MultiCross Catheter, CEMCX-01002017-08-09
B094UC01000CenterCross Ultra CatheterUC-01002017-04-12
00858480007008CenterCross CatheterCC-01002017-08-24
00858480007046MultiCross CatheterMC-01002017-08-24
00858480007053CenterCross Ultra CatheterUC-01002017-08-24
00858480007060CenterCross Ultra LV CatheterLV-01002017-08-30
00858480007077CenterCross Catheter,CECCX-01002018-04-19
00858480007084MultiCross Catheter, CEMCX-01002018-04-19
00858480007091CenterCross Ultra Catheter, CEUCX-01002018-04-19
00858480007015Micro14 MicroCross CatheterRC-00142017-08-24
00858480007022Micro18 MicroCross CatheterRC-00182017-08-24
00858480007039Micro14es MicroCross CatheterRC-10142017-08-24
00858480007107Micro14 MicroCross Catheter,CERCX-00142018-04-19
00858480007114Micro14es MicroCross Catheter, CERCX-10142018-04-19
00858480007121Micro18 MicroCross Catheter, CERCX-00182018-04-19
00858480007138MicroCross 14 Catheter, 135cmRC-20142018-09-20

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