Catalog Number

0250040103

Brand Name

NA

Version/Model Number

0250040103

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 15, 2019

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

08c2c2e7-d599-409b-bd91-6caa03ad7c67

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

37613327061452

Quantity per Package

3

Contains DI Package

07613327061451

Package Discontinue Date

February 15, 2019

Package Status

Not in Commercial Distribution

Package Type

pack