Catalog Number

007545012701

Brand Name

HyVee

Version/Model Number

007545012701

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

1e2d5fbb-8e49-4243-a500-4c6832b6a57b

Public Version Date

November 20, 2018

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

10075450127017

Quantity per Package

6

Contains DI Package

00075450127010

Package Discontinue Date

April 30, 2018

Package Status

Not in Commercial Distribution

Package Type

case