Catalog Number

SJO-29-S

Brand Name

Sonnet

Version/Model Number

G34159

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

FDI

Product Code Name

SNARE, FLEXIBLE

Public Device Record Key

024401ca-33a4-4188-b661-68fb144fe9e6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10827002341590

Quantity per Package

10

Contains DI Package

00827002341593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-