Catalog Number

653

Brand Name

Dale Bendable Armboard

Version/Model Number

653

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYH

Product Code Name

Splint, Extremity, Noninflatable, External, Sterile

Public Device Record Key

ce274707-a59f-4713-8fc0-fe90c9fbf3d9

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 29, 2018

Package DI Number

H84106532

Quantity per Package

10

Contains DI Package

H84106531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box