Catalog Number

-

Brand Name

NONE

Version/Model Number

470500

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

Yes

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

-

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

b2e3a4f4-b2a2-459a-a2e5-9239b3d221e1

Public Version Date

March 02, 2020

Public Version Number

2

DI Record Publish Date

February 12, 2020

Package DI Number

30886874116402

Quantity per Package

16

Contains DI Package

10886874116408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE