Catalog Number

SYK41-915-11

Brand Name

Arm Board / Utility Pads

Version/Model Number

SYK41-915-11

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"

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

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

db2606ed-fa5b-4d5f-8859-b9d9b4ab44e3

Public Version Date

December 11, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2019

Package DI Number

00850013699469

Quantity per Package

3

Contains DI Package

10850013699466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

3