Catalog Number

24003DS

Brand Name

BERT®

Version/Model Number

24003DS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033842,K033842

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

8eaafdd2-5a24-4d15-808b-1fc2dc97a9df

Public Version Date

May 20, 2022

Public Version Number

1

DI Record Publish Date

May 12, 2022

Package DI Number

05019829240073

Quantity per Package

10

Contains DI Package

05019829239930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box