Catalog Number

20402-201

Brand Name

ERBE

Version/Model Number

20402-201

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

K190651

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

719cc18e-542b-404f-b46e-fcd890feb295

Public Version Date

March 31, 2020

Public Version Number

1

DI Record Publish Date

March 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-