Catalog Number

617938

Brand Name

H.E.B Wart Freezer

Version/Model Number

617938

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

686beb59-d53d-4942-bce6-5b7b178bd9c1

Public Version Date

July 12, 2018

Public Version Number

2

DI Record Publish Date

June 08, 2018

Package DI Number

10041220613127

Quantity per Package

6

Contains DI Package

00041220613120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case