Catalog Number

7207951S

Brand Name

NA

Version/Model Number

7207951S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 23, 2020

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"

-

For Single-Use

-

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

K980604

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

24a10b5b-b1f0-4220-aee2-cc53530600cd

Public Version Date

October 26, 2020

Public Version Number

4

DI Record Publish Date

September 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-