Catalog Number

500010

Brand Name

ALP®

Version/Model Number

ALP® 2 CALF-XL

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)

Yes

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

K955853,K955853

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

054dc912-3117-48c8-8fc0-2c1469114617

Public Version Date

August 05, 2019

Public Version Number

1

DI Record Publish Date

July 26, 2019

Package DI Number

00857910006543

Quantity per Package

20

Contains DI Package

00857910006048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case 10 Pr