Catalog Number

-

Brand Name

Lifestart

Version/Model Number

LSA106

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MMP

Product Code Name

Cover, barrier, protective

Public Device Record Key

14163949-0b0b-4d16-a3f1-8751171f13ad

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 20, 2016

Package DI Number

05060195340720

Quantity per Package

20

Contains DI Package

05060195340706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box