Catalog Number

-

Brand Name

Hydrofilm 10x15cm st P50 C10

Version/Model Number

6857601

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

1aa91511-b157-424c-a73b-f1ba82123044

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Package DI Number

04049500631051

Quantity per Package

50

Contains DI Package

04049500631068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-