Catalog Number

-

Brand Name

Syvek SP Patch

Version/Model Number

400-12

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

ae439006-8bdf-45f1-866c-cca36417f600

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 20, 2020

Package DI Number

10389142000107

Quantity per Package

6

Contains DI Package

00389142000100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box