Catalog Number

552

Brand Name

Dale Strapless Bendable Armboard

Version/Model Number

552

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

0a73a66b-bb1d-49d4-95e8-130488e2e557

Public Version Date

September 22, 2020

Public Version Number

1

DI Record Publish Date

September 14, 2020

Package DI Number

00817612021015

Quantity per Package

10

Contains DI Package

00817612021008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box