Darby Dental Supply, LLC - GERM TRAY W/SS LD - BEIGE DARBY - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: GERM TRAY W/SS LD - BEIGE DARBY

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More Product Details

Catalog Number

9905710

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9905710

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)

Yes

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

ed850fd8-1d09-414f-b311-b15aadaa1d36

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

July 25, 2019

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