Catalog Number

5252681

Brand Name

Darby Dental Supply, LLC

Version/Model Number

5252681

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

c22b67f6-5bfe-4c21-a2e4-1a991a858f67

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-