Darby Dental Supply, LLC - CEMENT SPATULA SS #24 FLEXI - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: CEMENT SPATULA SS #24 FLEXI

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More Product Details

Catalog Number

9508854

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9508854

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

GAF

Product Code Name

SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

c4a9c267-d54a-4590-8075-cae24ed8f52d

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