Catalog Number

9508264

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9508264

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K931202,K931202,K931202

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

daf6d302-646c-4bf6-b6a6-a46802d3ebaf

Public Version Date

January 04, 2021

Public Version Number

4

DI Record Publish Date

February 14, 2018

Package DI Number

00889813012987

Quantity per Package

5

Contains DI Package

00889813012925

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE