Duns Number:088514898
Device Description: Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Re Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-filled glass syringes.
Catalog Number
-
Brand Name
Rebiject II
Version/Model Number
U6722302
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
-
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
4239b595-3712-4ca5-a1cf-92a75d744801
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |