Catalog Number

-

Brand Name

Greenwald Surgical Company, Inc.

Version/Model Number

C8120-12

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KOA

Product Code Name

Surgical Instruments, G-U, Manual (And Accessories)

Public Device Record Key

0cb84803-fcd9-47a4-b717-a1531e9b50d8

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

May 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-