Clip-on Spacers for Rebif

Basic Information

• Brand Name: Clip-on Spacers for Rebif
• Primary DI: 04054839025914
• Version / Model: U6744004
• Company Name: EMD SERONO, INC.
• Labeler DUNS: 088514898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 51b1f43c-7eda-468a-80f8-c645156f1fb9

Device Description

Titration Clip for Dose Titration using Rebif® 22 mcg or 44 mcg Pre-filled Syringe.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61635	Syringe plunger stop	A small non-sterile device intended to be attached to the plunger of a syringe to limit the movement of the plunger, so that less than the full volume of medication, or other substance, within the syringe can be ejected. It is typically made of plastic materials and is available in a range of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04054839025914	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]