Catalog Number

ST816

Brand Name

Centurion

Version/Model Number

ST816

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)

-

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

KXG

Product Code Name

APPLICATOR, ABSORBENT TIPPED, STERILE

Public Device Record Key

99768812-f5b4-47ac-954e-03ad34e1dc60

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

January 02, 2022

Package DI Number

50653160000073

Quantity per Package

100

Contains DI Package

00653160000078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE