Darby Dental Supply, LLC - Air/Water Syringe Sani-Tip Clear - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: Air/Water Syringe Sani-Tip Clear

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More Product Details

Catalog Number

9528894

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9528894

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

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

-

Product Code Details

Product Code

ECB

Product Code Name

UNIT, SYRINGE, AIR AND/OR WATER

Device Record Status

Public Device Record Key

870c38ba-c7a7-4a48-ac5e-9d750aeb6af4

Public Version Date

June 13, 2019

Public Version Number

1

DI Record Publish Date

June 05, 2019

Additional Identifiers

Package DI Number

20889813024663

Quantity per Package

50

Contains DI Package

00889813024669

Package Discontinue Date

-

Package Status

In Commercial Distribution

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