Catalog Number

D5121

Brand Name

Fresh® clear

Version/Model Number

D5121

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 10, 2022

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K053427

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

91909fe4-5882-416b-8a92-d4c306c6eece

Public Version Date

January 11, 2022

Public Version Number

5

DI Record Publish Date

October 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-