Darby Dental Supply, LLC - GLOVES NITRIL DX PF HNDSON MD DARBY - DARBY DENTAL SUPPLY, LLC

Duns Number:825137818

Device Description: GLOVES NITRIL DX PF HNDSON MD DARBY

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More Product Details

Catalog Number

3273522

Brand Name

Darby Dental Supply, LLC

Version/Model Number

3273522

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LZA

Product Code Name

Polymer patient examination glove

Device Record Status

Public Device Record Key

17841d54-0384-4fe7-820a-2594f12ae64b

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

July 19, 2018

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