Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

LS7020

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

b63c4683-4ee6-4721-ac1e-4676b3a88d0a

Public Version Date

July 27, 2022

Public Version Number

5

DI Record Publish Date

March 10, 2021

Package DI Number

10385640054918

Quantity per Package

10

Contains DI Package

00385640054911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box