Surefire Guiding Catheter

GUDID 00857136004064

65cm. 5F Guiding Catheter with Sim1 Shape

SUREFIRE MEDICAL, INC.

Vascular guide-catheter, single-use
Primary Device ID00857136004064
NIH Device Record Key076022ec-9fc4-4f7f-ad98-bfc07a041dec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurefire Guiding Catheter
Version Model NumberSGC-5065-Sim1
Company DUNS832575497
Company NameSUREFIRE 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length65 Centimeter
Length65 Centimeter
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter
Catheter Gauge5 French
Lumen/Inner Diameter0.056 Inch
Length65 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100857136004064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


[00857136004064]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2016-09-08

On-Brand Devices [Surefire Guiding Catheter]

0085713600407165cm, 5F Guiding Catheter with Axis Shape
0085713600406465cm. 5F Guiding Catheter with Sim1 Shape
0085713600405765cm, 5F Guiding Catheter with Cobra1 Shape

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