Catalog Number

HEAALP1A

Brand Name

NA

Version/Model Number

HEAALP1A

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

K012597,K012597

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

18576e68-f4d3-44c5-add6-cd9dbce1e7e0

Public Version Date

August 14, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

20888551042236

Quantity per Package

10

Contains DI Package

10888551042239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton