Burkhart Dental Supply - Violet Blue SM Nitrile PF Txt Glove (200) - BURKHART DENTAL SUPPLY CO., THE

Duns Number:027532357

Device Description: Violet Blue SM Nitrile PF Txt Glove (200)

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More Product Details

Catalog Number

-

Brand Name

Burkhart Dental Supply

Version/Model Number

72721570

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)

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

e4e06212-4149-485f-8957-124f8c2b81b5

Public Version Date

August 18, 2022

Public Version Number

1

DI Record Publish Date

August 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BURKHART DENTAL SUPPLY CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 214
2 A medical device with a moderate to high risk that requires special controls. 43