Catalog Number

TM500DE

Brand Name

DeRoyal

Version/Model Number

TM500DE

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

NWV

Product Code Name

Laparoscopic accessories, gynecologic

Public Device Record Key

628d028b-5027-4d7d-bf77-3b0d1aaa6868

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Package DI Number

50749756791378

Quantity per Package

10

Contains DI Package

00749756791373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case