Catalog Number

I68020K

Brand Name

Centurion

Version/Model Number

I68020K

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

GEN

Product Code Name

FORCEPS, GENERAL & PLASTIC SURGERY

Public Device Record Key

aff3344e-4678-4f6b-8602-439287ce8b35

Public Version Date

April 05, 2022

Public Version Number

1

DI Record Publish Date

March 28, 2022

Package DI Number

00653160351262

Quantity per Package

20

Contains DI Package

10653160351269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE