Catalog Number

981896

Brand Name

CVS Health

Version/Model Number

981896

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2016

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

4ab4ae6a-b850-43f6-952a-f0bb376eaf20

Public Version Date

July 12, 2018

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

10050428276058

Quantity per Package

6

Contains DI Package

00050428276051

Package Discontinue Date

October 07, 2016

Package Status

Not in Commercial Distribution

Package Type

Case