Catalog Number

SCXXA

Brand Name

Advance Dental Products

Version/Model Number

SCXXA

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)

-

Over the Counter (OTC)

-

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

aa26707a-fa7f-4aca-b1d0-a7fd0558c0cd

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

February 15, 2019

Package DI Number

20850455007598

Quantity per Package

20

Contains DI Package

10850455007591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case