Catalog Number

-

Brand Name

Syvek Brace with Straps

Version/Model Number

420-05

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)

Yes

Over the Counter (OTC)

-

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

05569042-fab1-4fd7-971b-735dbb84454e

Public Version Date

October 30, 2020

Public Version Number

1

DI Record Publish Date

October 22, 2020

Package DI Number

10389142000039

Quantity per Package

20

Contains DI Package

00389142000032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box