Catalog Number

NSLX137S

Brand Name

Harmonic

Version/Model Number

NSLX137S

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

K201696,K201696

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

bdf3d987-06a7-4cbf-92eb-41fe06e0c9e8

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 13, 2021

Package DI Number

20705036015489

Quantity per Package

3

Contains DI Package

10705036015482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX