Catalog Number

-

Brand Name

BodyGuard® Microset

Version/Model Number

A100-163XE90S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 22, 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

K042696,K042696

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

ec2dfe17-b138-4ef7-b5c2-ccaa693a2e71

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

June 15, 2017

Package DI Number

10818666020181

Quantity per Package

50

Contains DI Package

00818666020184

Package Discontinue Date

July 22, 2020

Package Status

Not in Commercial Distribution

Package Type

Case