Catalog Number

71-CPLF

Brand Name

DeRoyal

Version/Model Number

71-CPLF

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"

Yes

For Single-Use

Yes

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

-

Product Code

EYH

Product Code Name

TABLE, CYSTO, NON-ELECTRICAL

Public Device Record Key

bd68f8dc-4314-4a1a-a1aa-a4bee46fb26f

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

50749756629176

Quantity per Package

10

Contains DI Package

00749756629171

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case