Catalog Number

NS2013US

Brand Name

NovaSure

Version/Model Number

2013

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P010013,P010013,P010013,P010013

Product Code

MNB

Product Code Name

DEVICE, THERMAL ABLATION, ENDOMETRIAL

Public Device Record Key

4f4976c9-121a-4be7-a517-e2675237f439

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2014

Package DI Number

25420045501116

Quantity per Package

1

Contains DI Package

15420045501119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX