Catalog Number

1188-020-122

Brand Name

1188

Version/Model Number

1188020122

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2020

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

K142603

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

42ff9c4c-ad88-4197-b638-0ca08ebf3c3d

Public Version Date

March 19, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-