Catalog Number

14047836710

Brand Name

Bath insert Medite/Hacker 20

Version/Model Number

000000014047836710

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KIM

Product Code Name

DEVICE FOR SEALING MICROSECTIONS

Public Device Record Key

4db640f7-ec2e-4d24-99dd-b8327b561f85

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

December 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-