Catalog Number

-

Brand Name

Single-Site

Version/Model Number

478065

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

cb4c0dfb-554c-4e0e-b9c6-d49a02b2af67

Public Version Date

March 02, 2020

Public Version Number

4

DI Record Publish Date

July 08, 2016

Package DI Number

10886874113674

Quantity per Package

10

Contains DI Package

00886874113677

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX