Catalog Number

-

Brand Name

Derma-Stent

Version/Model Number

DMT

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"

-

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

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

79a8797d-4465-4c07-9d27-61d95851c01c

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2020

Package DI Number

10855364004105

Quantity per Package

20

Contains DI Package

00855364004108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box