Centurion - CENTURION MEDICAL PRODUCTS CORPORATION

Duns Number:017246562

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More Product Details

Catalog Number

-

Brand Name

Centurion

Version/Model Number

ST450ST

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

BYY

Product Code Name

TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Device Record Status

Public Device Record Key

3d6245ab-b12d-4ec0-b20c-d6b5a6c6c604

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

50653160047719

Quantity per Package

100

Contains DI Package

00653160047714

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