Catalog Number

SleeveS

Brand Name

Protech Proguard

Version/Model Number

SleeveS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KPY

Product Code Name

Shield, Protective, Personnel

Public Device Record Key

40d7bea7-441c-47ec-934e-d8275e510781

Public Version Date

April 16, 2018

Public Version Number

1

DI Record Publish Date

March 15, 2018

Package DI Number

08054301890947

Quantity per Package

3

Contains DI Package

08054301890206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-