Catalog Number

V28-0207

Brand Name

DeRoyal

Version/Model Number

V28-0207

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

859e9e73-98c6-4c6a-b4b4-71bcd2821bf3

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Package DI Number

50749756296798

Quantity per Package

20

Contains DI Package

00749756296793

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case