Catalog Number

-

Brand Name

Medichoice

Version/Model Number

LAC2028

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K920517,K920517

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

573c0549-adf9-456d-b40f-ee96de3881e3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 20, 2016

Package DI Number

50885632134935

Quantity per Package

20

Contains DI Package

10885632134937

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-