NA - Vessel Dilator - ST. JUDE MEDICAL, INC.

Duns Number:149818952

Device Description: Vessel Dilator

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More Product Details

Catalog Number

405524

Brand Name

NA

Version/Model Number

405524

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"

-

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

K894330,K894330

Product Code Details

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Record Status

Public Device Record Key

50b9922c-3b24-4808-9994-e314985615f3

Public Version Date

February 24, 2022

Public Version Number

1

DI Record Publish Date

February 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ST. JUDE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 70
2 A medical device with a moderate to high risk that requires special controls. 1429
3 A medical device with high risk that requires premarket approval 736