Catalog Number

2000A-B

Brand Name

Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8

Version/Model Number

2000A-B

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

K101598,K101598

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

bbd5ccd0-f59b-448e-be7f-2ac9e61ff428

Public Version Date

December 10, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10869653000228

Quantity per Package

12

Contains DI Package

00869653000221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case