Catalog Number

0240-060-140

Brand Name

Connect OR OS

Version/Model Number

0240060140

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

K160332

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

e290a20f-d314-4a8f-9877-296bd0e70b2b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-