Catalog Number

-

Brand Name

Microtek

Version/Model Number

Model PSKB100F

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMQ

Product Code Name

Restraint, protective

Public Device Record Key

cbcfa61d-e9c1-4295-b2d2-b1ed5c3eb5d6

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Package DI Number

26931918118854

Quantity per Package

100

Contains DI Package

16931918118857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton