Catalog Number

0250040116

Brand Name

NA

Version/Model Number

0250040116

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

K934094,K934094

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

e35d2362-793e-47ce-89ba-585c4e5e1a6d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

37613327061278

Quantity per Package

3

Contains DI Package

07613327061277

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack