Catalog Number

DUP31805

Brand Name

MediHoney®

Version/Model Number

31805

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

ff7537f5-8925-4367-8d19-c7b8562b6bd6

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

September 14, 2018

Package DI Number

30381780486972

Quantity per Package

4

Contains DI Package

10381780486978

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case