Latex Exam XS PF Txt Gloves (100) - BURKHART DENTAL SUPPLY CO., THE

Duns Number:027532357

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More Product Details

Catalog Number

-

Brand Name

Latex Exam XS PF Txt Gloves (100)

Version/Model Number

72720616

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

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

LYY

Product Code Name

Latex Patient Examination Glove

Device Record Status

Public Device Record Key

a7be9f43-7b33-47a7-84cd-eaa3044a5721

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2019

Additional Identifiers

Package DI Number

00815878021992

Quantity per Package

100

Contains DI Package

00815878021947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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