Catalog Number

SIR650

Brand Name

Sempermed Syntegra IR Polyisoprene Surgical Glove

Version/Model Number

SIR650

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

045b1683-b0c2-485e-b6f6-061489d501c4

Public Version Date

May 02, 2022

Public Version Number

1

DI Record Publish Date

April 22, 2022

Package DI Number

10841277106302

Quantity per Package

6

Contains DI Package

00841277106305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-