Catalog Number

20416-031

Brand Name

ERBE

Version/Model Number

20416-031

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

K051509

Product Code

GEH

Product Code Name

UNIT, CRYOSURGICAL, ACCESSORIES

Public Device Record Key

1c07c240-078b-473d-8f7e-a726ca0f1b1f

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-