XableCath XC-014-145A

GUDID 00853989006026

XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions.

ZIEN MEDICAL TECHNOLOGIES, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00853989006026
NIH Device Record Keyb9fa2be6-99d1-4ba3-8ad1-f5f4747d5060
Commercial Distribution StatusIn Commercial Distribution
Brand NameXableCath
Version Model NumberXC-014-145A
Catalog NumberXC-014-145A
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, 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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Length145 Centimeter
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter
Guidewire Diameter0.014 Inch
Catheter Length145 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100853989006026 [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 Number3
Public Version Date2019-01-23
Device Publish Date2018-09-24

On-Brand Devices [XableCath]

00853989006170XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006163XableCath is an over-th-wire catheter for facilitating guide wire and catheter access in periphe
00853989006156XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006149XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006132XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006125XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006118XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006101XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006095XableCath is an over the wire catheter for facilitating guide wire and catheter access to periph
00853989006088XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006071XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006064XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006057XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006040XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006033XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006026XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006019XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph
00853989006002XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in periph

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