XRay Apron - Operator Apron with Collar LeadFree XRay - Kerr Corporation

Duns Number:199354556

Device Description: Operator Apron with Collar LeadFree XRay Protection Apron Charcoal Microfiber .5mm

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More Product Details

Catalog Number

-

Brand Name

XRay Apron

Version/Model Number

31392DX

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

-

Prescription Use (Rx)

Yes

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

IWO

Product Code Name

Apron, protective

Device Record Status

Public Device Record Key

b7478d23-fbfc-4ce6-af5e-7c6bc4e27ab6

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KERR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 98
2 A medical device with a moderate to high risk that requires special controls. 595
U Unclassified 5