Catalog Number

-

Brand Name

Skytrofa Auto-Injector

Version/Model Number

1002247

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KZH

Product Code Name

Introducer, Syringe Needle

Public Device Record Key

30303305-0891-4975-9f3f-2d55c0e2376b

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Package DI Number

05713495000084

Quantity per Package

10

Contains DI Package

05713495000077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-