Catalog Number

SL-155

Brand Name

SightLine

Version/Model Number

SL-155

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

HWT

Product Code Name

Template

Public Device Record Key

09e36e5f-d529-4edb-8f37-249ca13fcb1c

Public Version Date

May 13, 2022

Public Version Number

2

DI Record Publish Date

August 23, 2019

Package DI Number

00810004722316

Quantity per Package

10

Contains DI Package

00810004721852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-