Catalog Number

PEU-K01

Brand Name

Permablate

Version/Model Number

PEU-K01

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HPY

Product Code Name

Unit, Electrolysis, Battery-Powered, Ophthalmic

Public Device Record Key

7515164c-a426-47ca-ac3c-d7496cdd79d0

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

November 13, 2020

Package DI Number

00860004198833

Quantity per Package

32

Contains DI Package

00860004198826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton