Catalog Number

D5910-18U

Brand Name

Surgical One

Version/Model Number

D5910-18U

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

a98b665a-8742-4f25-ac08-471080836e81

Public Version Date

July 08, 2020

Public Version Number

1

DI Record Publish Date

June 30, 2020

Package DI Number

00850015378805

Quantity per Package

20

Contains DI Package

00850015378799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case