Defend - DISPOSABLE LAB COAT - MEDIUM 10/BAG (LAVENDER) - YOUNG MYDENT, LLC

Duns Number:081330555

Device Description: DISPOSABLE LAB COAT - MEDIUM 10/BAG (LAVENDER)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SG-9014

Brand Name

Defend

Version/Model Number

SG-9014

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

FME

Product Code Name

Gown, Examination

Device Record Status

Public Device Record Key

4ee562da-865d-4f93-bac7-33a5bbc94e56

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

March 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"YOUNG MYDENT, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 61
2 A medical device with a moderate to high risk that requires special controls. 103