Catalog Number

106023

Brand Name

Arm Support

Version/Model Number

106023

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

-

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

K060737

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

0a5f39f5-f807-465b-8e8e-0d241070977a

Public Version Date

November 10, 2020

Public Version Number

10

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-