Centurion - FCP MAGILL CATH 8IN PED (67575) - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

Device Description: FCP MAGILL CATH 8IN PED (67575)

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More Product Details

Catalog Number

67575

Brand Name

Centurion

Version/Model Number

67575

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

-

Product Code Details

Product Code

BWB

Product Code Name

FORCEPS, TUBE INTRODUCTION

Device Record Status

Public Device Record Key

a543a7ba-33c5-4c0a-ae9b-befc2feb47d0

Public Version Date

April 19, 2022

Public Version Number

1

DI Record Publish Date

April 11, 2022

Additional Identifiers

Package DI Number

00653160352054

Quantity per Package

20

Contains DI Package

10653160352051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CENTURION MEDICAL PRODUCTS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6043
2 A medical device with a moderate to high risk that requires special controls. 4077
U Unclassified 1