AccessGUDID - DEVICE: Rebiject II (04054839025808)

GUDID

Device Identifier (DI) Information

Brand Name: Rebiject II
Version or Model: U6722302
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EMD Serono, Inc.

Primary DI Number: 04054839025808
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 088514898 *Terms of Use

Device Description: Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-filled glass syringes.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62117	Syringe-loaded medication/vaccine injector, manual, home-use	A hand-held, manually-powered, mechanical device intended to be used in conjunction with an appropriate plunger syringe and needle for the self-administration of a medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. It is typically a spring-loaded mechanical assembly intended to accept a prefilled syringe and needle; the syringe, needle and pharmaceutical are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZH	Introducer, Syringe Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4239b595-3712-4ca5-a1cf-92a75d744801
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: August 26, 2016