FDA.reportPublic FDA data

Coeur

Primary DI
M297731020
Brand
Coeur
Company
COEUR, INC.
Model
C853-3102
Catalog number
C853-3102
Device description
" 200mL Single Syringe Kit for Stellant Injectors (Includes 1-200mL Syringes, 1-60"" Y-line, and 1 Spike"
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170431000CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram TipCoeur, Inc.2017-08-18DXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M297731026PackageHIBCC50In Commercial Distribution
M297731020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume200Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep product in clean, dry location. Avoid direct rays, heat and high humidity, and ultraviolet rays such as a germicidal light.

Contacts#

Phone, Email table
PhoneEmail
1-800-296-5893customerservice@coeurinc.com

Regulatory Flags#

DUNS number
132515441
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M297722010CoeurC853-2201C853-22012019-02-11
M297722070CoeurC853-2207C853-22072019-02-11
M297732010CoeurC853-3201C853-32012019-02-11
M297732020CoeurC853-3202C853-32022019-02-11
M297100600CoeurC405-0060C405-00602016-07-14
M297100610CoeurC405-0061C405-00612016-07-14
M297101230CoeurC405-0123C405-01232016-07-14
M297102010CoeurC405-0201C405-02012016-07-14
M297102030CoeurC405-0203C405-02032016-07-14
M297115010CoeurC405-1501C405-15012016-07-14
M297115080CoeurC405-1508C405-15082016-07-14
M297115490CoeurC405-1549C405-15492016-07-14
M297115590CoeurC405-1559C405-15592016-07-14
M297115690CoeurC405-1569C405-15692016-07-14
M297118010CoeurC405-1801C405-18012016-07-14
M297118020CoeurC405-1802C405-18022016-07-14
M297120410CoeurC405-2041C405-20412016-07-14
M297120420CoeurC405-2042C405-20422016-07-14
M297121550CoeurC405-2155C405-21552016-07-14
M297126010CoeurC405-2601C405-26012016-07-14

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Primary DI, Brand, Company table
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09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
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