Catalog Number

-

Brand Name

GloShield

Version/Model Number

17-2001

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

NWV

Product Code Name

Laparoscopic Accessories, Gynecologic

Public Device Record Key

0c987019-3016-4e16-aa38-bcce33330e0a

Public Version Date

May 04, 2018

Public Version Number

1

DI Record Publish Date

April 03, 2018

Package DI Number

10860100001812

Quantity per Package

20

Contains DI Package

00860100001815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case