Coeur - 200mL Dual-Syringe Kit for Stellant Injectors - COEUR, INC.

Duns Number:132515441

Device Description: 200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60" Y-line, 1 200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60" Y-line, 1 Contrast Spike, and 1-Saline Spike

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More Product Details

Catalog Number

C853-3202

Brand Name

Coeur

Version/Model Number

C853-3202

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170431,K170431

Product Code Details

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

0c069052-6f29-4a58-b8d5-6a51d77a4bc2

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 11, 2019

Additional Identifiers

Package DI Number

M297732026

Quantity per Package

50

Contains DI Package

M297732020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper

"COEUR, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 71