Catalog Number

-

Brand Name

Model 2450 Somnoplasty

Version/Model Number

2420-1328-05

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

K020778,K020778

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

ecdf3a66-1076-463a-9b41-66fa509c0a13

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

00821925009424

Quantity per Package

5

Contains DI Package

00821925041684

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-