Catalog Number

-

Brand Name

CORRECT TOUCH

Version/Model Number

FFNT102

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMC

Product Code Name

Patient Examination Glove

Public Device Record Key

28f6b7b7-fd68-49e3-be81-d6e4fdc13fe1

Public Version Date

August 10, 2021

Public Version Number

1

DI Record Publish Date

August 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-