Duns Number:300220969
Device Description: The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa® The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for use with Glatopa® (Glatiramer Acetate Injection) Pre-Filled Syringe.
Catalog Number
49020084
Brand Name
Glatopaject®
Version/Model Number
49036228
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
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
dfa2b457-fdb9-48a1-8d9e-9dea8610a363
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-