Catalog Number

22301

Brand Name

Kisol

Version/Model Number

22301

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 07, 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

Yes

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

-

Product Code

EHY

Product Code Name

Tray, Impression, Preformed

Public Device Record Key

47be3964-bafa-4250-bc53-6fc672ee1d85

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

November 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-