Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

LS7012

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"

-

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Public Device Record Key

e155fa2f-aeac-4897-b134-f3173691f543

Public Version Date

July 27, 2022

Public Version Number

2

DI Record Publish Date

September 03, 2021

Package DI Number

10385640052013

Quantity per Package

10

Contains DI Package

00385640052016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box