Catalog Number

NSV5KITUS-001

Brand Name

NovaSure

Version/Model Number

V5

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

Yes

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

-

FDA Premarket Submission

P010013

Product Code

MNB

Product Code Name

Device, thermal ablation, endometrial

Public Device Record Key

48890500-6d3e-40e5-bd23-8a87b1ab9b13

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-