Catalog Number

NS2000US

Brand Name

NovaSure

Version/Model Number

2000

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

Product Code

MNB

Product Code Name

DEVICE, THERMAL ABLATION, ENDOMETRIAL

Public Device Record Key

1da266fd-a9db-42a1-9eb7-d8de40669415

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2014

Package DI Number

25420045501147

Quantity per Package

1

Contains DI Package

15420045501140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX