MEDRAD® Stellant Sterile Disposable Syringe - STLNT,KIT,SYR,CT,DUAL,TCON,SPK,MC,WLD (86698188) - BAYER MEDICAL CARE INC.

Duns Number:058716649

Device Description: STLNT,KIT,SYR,CT,DUAL,TCON,SPK,MC,WLD (86698188)

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More Product Details

Catalog Number

SDS-CTP-SPK

Brand Name

MEDRAD® Stellant Sterile Disposable Syringe

Version/Model Number

SDS-CTP-SPK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

K023183,K023183

Product Code Details

Product Code

DXT

Product Code Name

Injector And Syringe, Angiographic

Device Record Status

Public Device Record Key

ab4ee3e3-4461-4446-8347-04bae8885868

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

40616258022138

Quantity per Package

20

Contains DI Package

00616258022130

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-

"BAYER MEDICAL CARE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 360