Catalog Number

-

Brand Name

Model 1120 Somnoplasty

Version/Model Number

1120-4110-05

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

K973618,K973618

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

0d52ef5c-0388-4162-9332-1f28a8b04e01

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

00821925010727

Quantity per Package

5

Contains DI Package

00821925037977

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-