Pro-Tek-To Pad - Pro-Tek-To Pad, Tye Dye - FLOW X RAY CORPORATION

Duns Number:010016319

Device Description: Pro-Tek-To Pad, Tye Dye

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More Product Details

Catalog Number

-

Brand Name

Pro-Tek-To Pad

Version/Model Number

75057-30

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)

-

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

KPY

Product Code Name

Shield, Protective, Personnel

Device Record Status

Public Device Record Key

fc4245bb-594a-41c3-bbf0-6ac1b6aefbb5

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

August 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLOW X RAY CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3215