Catalog Number

1688-210-105

Brand Name

1688

Version/Model Number

1688210105

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182160

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

86b22dcc-55b7-49a3-b089-f616c1d2051f

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-