Catalog Number

-

Brand Name

L360 Thigh System

Version/Model Number

L4T-6000

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

-

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

K191587

Product Code

GZI

Product Code Name

STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

Public Device Record Key

ac740172-a410-418a-9dde-8ed330a032bf

Public Version Date

October 08, 2019

Public Version Number

1

DI Record Publish Date

September 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-