Catalog Number

SIR800

Brand Name

Sempermed Syntegra IR Polyisoprene Surgical Glove

Version/Model Number

SIR800

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

4b030bb9-bf74-4e97-910d-1478bf87015c

Public Version Date

April 20, 2022

Public Version Number

3

DI Record Publish Date

January 01, 2020

Package DI Number

10841277102731

Quantity per Package

4

Contains DI Package

00841277102734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-