Catalog Number

-

Brand Name

Centurion

Version/Model Number

LT435ST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

BYY

Product Code Name

TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Public Device Record Key

924a770b-ccfc-4acb-976d-e714ed939bb7

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

September 14, 2016

Package DI Number

00653160281422

Quantity per Package

50

Contains DI Package

10653160281429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE