Darby Dental Supply, LLC - EXPLORER 23 SE 04-923 DARBY - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: EXPLORER 23 SE 04-923 DARBY

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

9550108

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9550108

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

-

Product Code Details

Product Code

EKB

Product Code Name

EXPLORER, OPERATIVE

Device Record Status

Public Device Record Key

663738a8-9548-41b7-b0c7-eeb7a6dda054

Public Version Date

June 03, 2020

Public Version Number

1

DI Record Publish Date

May 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DARBY DENTAL SUPPLY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1457
2 A medical device with a moderate to high risk that requires special controls. 194
U Unclassified 2