Catalog Number

SY-911-M

Brand Name

MICROFLEX

Version/Model Number

SY-911-M

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

513800b2-00a0-41fe-8d51-1c443ca683da

Public Version Date

March 25, 2022

Public Version Number

1

DI Record Publish Date

March 17, 2022

Package DI Number

00769799091186

Quantity per Package

10

Contains DI Package

00769799091131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case