Catalog Number

-

Brand Name

Sklar®

Version/Model Number

31-9031XC

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K974382

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

04cacc35-009c-4fb8-9a80-097693c9305c

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

March 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-