Catalog Number

SCR550

Brand Name

Sempermed Syntegra CR Chloroprene Surgical Glove

Version/Model Number

SCR550

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

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

33cfe0c0-7615-48e9-9186-2113c7f87ec1

Public Version Date

July 16, 2020

Public Version Number

1

DI Record Publish Date

July 08, 2020

Package DI Number

10841277105947

Quantity per Package

6

Contains DI Package

00841277105940

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-