Catalog Number

RR385

Brand Name

Xguard

Version/Model Number

RR385

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

IWP

Product Code Name

Radiographic Protective Glove

Public Device Record Key

022fdfb2-668c-4d69-b674-ebba042874be

Public Version Date

April 16, 2018

Public Version Number

1

DI Record Publish Date

March 16, 2018

Package DI Number

08054301891142

Quantity per Package

3

Contains DI Package

08054301890404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-