Catalog Number

9508268

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9508268

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

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

80aec6e9-1ba2-4d6f-88d2-8d5d47c4c246

Public Version Date

January 04, 2021

Public Version Number

4

DI Record Publish Date

February 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-