Catalog Number

1000-4

Brand Name

AllergiEnd ST-9

Version/Model Number

1000-4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2021

Issuing Agency

In HIBCC

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

K172062

Product Code

LDH

Product Code Name

System, Delivery, Allergen And Vaccine

Public Device Record Key

5755d4b3-efc8-4556-9338-8fd17faaff67

Public Version Date

November 30, 2021

Public Version Number

2

DI Record Publish Date

November 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-