Catalog Number

-

Brand Name

BodyGuard® Microset with compression fit adapter

Version/Model Number

A120-160GCFA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2020

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

0d6e109e-5c97-471f-aa39-eb616b2a697d

Public Version Date

November 16, 2020

Public Version Number

5

DI Record Publish Date

June 16, 2017

Package DI Number

10818666020259

Quantity per Package

50

Contains DI Package

00818666020252

Package Discontinue Date

July 22, 2020

Package Status

Not in Commercial Distribution

Package Type

Case