Catalog Number

Gerstner-Moncover-01A

Brand Name

Dinamic OR Spine Rack Monitor Cover 60x64cm

Version/Model Number

Gerstner-Moncover-01A

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

0f611e61-5989-4a22-b7be-8a2b130abd7e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

00869653000214

Quantity per Package

100

Contains DI Package

00869653000207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case