Cardiovascular Procedure Kit - Terumo Cardiovascular Systems Corporation

Duns Number:177655466

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More Product Details

Catalog Number

-

Brand Name

Cardiovascular Procedure Kit

Version/Model Number

64162

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)

Yes

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

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

59491e1b-d35f-408e-9d81-60ce476986c8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 01, 2014

Additional Identifiers

Package DI Number

50699753456230

Quantity per Package

5

Contains DI Package

00699753456235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Piece Case

"TERUMO CARDIOVASCULAR SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 174