FDA.report

SUPER TORQUE

Primary DI
20705032013373
Brand
SUPER TORQUE
Company
CORDIS CORPORATION
Model
533653S
Catalog number
533653S
Device description
CATH F6 ST+ PIG 145MOD110CM6SH
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20705032013373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2070503201337320705032013373

GMDN Terms

TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damanged
Special Storage Condition, Specify00Store in cool, dark, dry place

Sterilization Methods

Method

Regulatory Flags

DUNS number
806136177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20705032062296PALMAZ BLUEPB2470PPSPB2470PPS2024-07-31
20705032065631SMART FLEXSF08030MBSF08030MB2024-07-31
20705032065839SMART FLEXSF10030SBSF10030SB2024-07-31
20705032065846SMART FLEXSF07030MBSF07030MB2024-07-31
20705032066164SMART FLEXSF09030SBSF09030SB2024-07-31
20705032066218SMART FLEXSF08030SBSF08030SB2024-07-31
20705032056660ATW595MX014595MX0142024-06-18
20705032026335SUPERTORQUE PLUSCP0291CP02912024-03-14
20705032026342SUPERTORQUE PLUSCP0292CP02922024-03-14
20705032045534SUPERTORQUE PLUSSR3466SR34662024-03-14
20705032049235SUPERTORQUESRD5846SRD58462024-03-14
20705032049891SUPERTORQUESRD6199SRD61992024-03-14

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