Catalog Number

20402-401

Brand Name

ERBE

Version/Model Number

20402-401

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

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

K190651,K190651

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

1dc1a820-1f2b-43ce-bc61-91d8e8620d94

Public Version Date

November 01, 2021

Public Version Number

2

DI Record Publish Date

February 07, 2020

Package DI Number

04050147021785

Quantity per Package

5

Contains DI Package

04050147021778

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level 1