Catalog Number

9508202

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9508202

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Public Device Record Key

5485e144-b637-4caa-8940-071c0938482c

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

May 19, 2016

Package DI Number

20889813000667

Quantity per Package

6

Contains DI Package

10889813000660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-