Catalog Number

8002

Brand Name

ST-9

Version/Model Number

8002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 30, 2025

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,K172062

Product Code

LDH

Product Code Name

System, Delivery, Allergen And Vaccine

Public Device Record Key

95206e99-1d32-40aa-b943-47f49b082b68

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Package DI Number

B682800217202103

Quantity per Package

36

Contains DI Package

B68280021

Package Discontinue Date

October 30, 2025

Package Status

In Commercial Distribution

Package Type

Bag