Catalog Number

AL7012

Brand Name

SmartPractice

Version/Model Number

AL7012

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

K013820,K013820

Product Code

LDH

Product Code Name

System, Delivery, Allergen And Vaccine

Public Device Record Key

a8cfbc41-8335-4204-b061-60172ae12785

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

December 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-