Catalog Number

SYN2034

Brand Name

Medline

Version/Model Number

SYN2034

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

-

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

573a987a-8f2c-41e6-94f5-d38992800263

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

October 14, 2016

Package DI Number

20888277635200

Quantity per Package

12

Contains DI Package

10888277635203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-