Catalog Number

403AB

Brand Name

Kentec ArmBoard

Version/Model Number

403AB

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

NOC

Product Code Name

Splint, Extremity, Non-Inflatable, External, Non-Sterile

Public Device Record Key

22be464b-8514-498b-97bc-a82154033539

Public Version Date

December 24, 2021

Public Version Number

1

DI Record Publish Date

December 16, 2021

Package DI Number

20817522010257

Quantity per Package

48

Contains DI Package

10817522010250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box