FDA.reportPublic FDA data

DEPUY CODMAN

Primary DI
20886704064869
Brand
DEPUY CODMAN
Company
CORDIS CORPORATION
Model
SRD5839
Catalog number
SRD5839
Device description
CATH FR.5 INF . 100CM
Published
2016-09-23
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
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914007000CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATHCordis Corp.1991-10-18DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704064869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670406486920886704064869

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is opened or damaged
Special Storage Condition, Specify00Exposure to temperatures above 54 degrees C (130 F) may damage the catheter
Special Storage Condition, Specify00Store in cool, dark, dry place
Special Storage Condition, Specify00To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000512AVANTI+402604T402604T2016-08-01
10705032000550AVANTI402605R402605R2016-08-01
10705032000772AVANTI+402611T402611T2016-08-01
10705032009751AVANTI504404X504404X2016-08-01
10705032009782AVANTI504407X504407X2016-08-01
10705032009805AVANTI504409X504409X2016-08-01
10705032009812AVANTI504504S504504S2016-08-01
10705032009829AVANTI504505S504505S2016-08-01
10705032009836AVANTI504505X504505X2016-08-01
10705032009843AVANTI504506S504506S2016-08-01
10705032009850AVANTI504506X504506X2016-08-01
10705032009867AVANTI504507X504507X2016-08-01
10705032009874AVANTI504508X504508X2016-08-01
10705032009928AVANTI504604T504604T2016-08-01
10705032009973AVANTI504605T504605T2016-08-01
10705032010009AVANTI504606D504606D2016-08-01
10705032010016AVANTI504606P504606P2016-08-01
10705032010023AVANTI504606S504606S2016-08-01
10705032010030AVANTI504606T504606T2016-08-01
10705032010054AVANTI504606X504606X2016-08-01

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