Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 50-150106

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

56632e11-3d04-4713-ac5a-8b9d64353316

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Package DI Number

26931918110889

Quantity per Package

36

Contains DI Package

16931918110882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton