OSTEOXPRESS

Basic Information

• Brand Name: OSTEOXPRESS
• Primary DI: 00815634020467
• Version / Model: GD-5515
• Company Name: Micromedics, Inc.
• Labeler DUNS: 066839630
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-13
• Public Version: 5
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: e04212db-db40-42fb-883b-f05296bd9c5e
• Distribution End Date: 2021-03-30

Device Description

GRAFT DELIVERY DEVICE - Molded Tray in Pouch

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: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
46119	Bone graft delivery kit	A collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10815634020464	GS1	SHELF BOX	5	Not in Commercial Distribution	2021-03-30
Primary	00815634020467	GS1

Premarket Submissions

Submission Number	Supplement Number
K151543	000