Catalog Number

NSLX120L

Brand Name

ENSEAL X1

Version/Model Number

NSLX120L

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

K163548,K163548

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

b5f9d939-ef79-49c0-8cf5-9a5e11b81183

Public Version Date

October 16, 2019

Public Version Number

4

DI Record Publish Date

February 21, 2017

Package DI Number

20705036015021

Quantity per Package

6

Contains DI Package

10705036015024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX