Catalog Number

10402-000

Brand Name

ERBE

Version/Model Number

10402-000

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

1e1a9732-5d00-4742-803c-cdd4794fec6b

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-