Latex Exam XL 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 XL PF Txt Gloves (100)

Version/Model Number

72720620

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

7696af1b-91d1-4fbb-988c-cedc58460121

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 24, 2019

Additional Identifiers

Package DI Number

00815878022036

Quantity per Package

100

Contains DI Package

00815878022029

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