Catalog Number

28-0213

Brand Name

DeRoyal

Version/Model Number

28-0213

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

NKC

Product Code Name

Tubing/tubing with filter, insufflation, laparoscopic

Public Device Record Key

574fd67f-0b8b-4937-9688-b76b63a531dc

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Package DI Number

50749756329281

Quantity per Package

20

Contains DI Package

00749756329286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case