Catalog Number

CER-ORTHO

Brand Name

CER-ORTHO

Version/Model Number

11 GA X 11.4 CM

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

K150563,K150563,K150563

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

ea2089d7-1845-46e7-a212-d2c4121fec41

Public Version Date

November 18, 2021

Public Version Number

1

DI Record Publish Date

November 10, 2021

Package DI Number

10850023741452

Quantity per Package

1

Contains DI Package

00850023741455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack