Catalog Number

C-LIL-TU-31

Brand Name

MICROLAP

Version/Model Number

C-LIL-TU-31

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 03, 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

K140101,K140101

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

f39bead6-5baf-4376-be36-2387c99863be

Public Version Date

December 03, 2020

Public Version Number

4

DI Record Publish Date

April 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-