Catalog Number

-

Brand Name

n.a.

Version/Model Number

10386AE

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K940427

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

7a5b7fec-eb7f-45b7-a377-6c5a5b662061

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-