Catalog Number

-

Brand Name

SteriCare Solutions

Version/Model Number

6240

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

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

K083042,K083042

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

85ef7bb8-1a1e-4539-870b-cc51faa76746

Public Version Date

September 15, 2021

Public Version Number

1

DI Record Publish Date

September 07, 2021

Package DI Number

10850421008812

Quantity per Package

48

Contains DI Package

00850421008815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-