Catalog Number

9518394

Brand Name

Darby Dental Supply, LLC

Version/Model Number

901-002606

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K870147,K870147,K870147

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

abddfc06-b15c-403b-853f-6f2f3d758be9

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

June 24, 2016

Package DI Number

20889813000742

Quantity per Package

12

Contains DI Package

10889813000745

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case