Catalog Number

5100-G

Brand Name

AMD-RITMED

Version/Model Number

5100-G

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

0ef7804b-9afb-4204-8ae1-da6f553c5d90

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-