Catalog Number

SEC2404320

Brand Name

StatLock

Version/Model Number

SEC2404320

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

1856577e-18d1-4c24-aee9-9c3148475737

Public Version Date

April 30, 2020

Public Version Number

1

DI Record Publish Date

April 22, 2020

Package DI Number

20801741188859

Quantity per Package

5

Contains DI Package

10801741188852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX