Catalog Number

-

Brand Name

Cranberry

Version/Model Number

CR8066_SP

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EIE

Product Code Name

Dam, Rubber

Public Device Record Key

1b973562-7a6f-460f-91c3-f4c9818cdf3e

Public Version Date

June 23, 2022

Public Version Number

2

DI Record Publish Date

December 27, 2021

Package DI Number

20817508022038

Quantity per Package

300

Contains DI Package

10817508022031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case