Catalog Number

-

Brand Name

Huntleigh

Version/Model Number

L501-M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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

K012654,K012654

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

60aae94e-a593-4551-91b8-fdf1332a2293

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

30817357021401

Quantity per Package

10

Contains DI Package

10817357021407

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box