Catalog Number

6537

Brand Name

AFFINIS

Version/Model Number

6537

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

-

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

K912485

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

0596eb73-955b-4547-a9b6-aa5053ba4f47

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 27, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-