BioHorizons

Basic Information

• Brand Name: BioHorizons
• Primary DI: 00847236015886
• Version / Model: BROTORZ
• Company Name: BIOHORIZONS IMPLANT SYSTEMS, INC
• Labeler DUNS: 967279910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-11
• Public Version: 1
• Public Version Date: 2021-01-19
• Public Version Status: New
• Public Device Record Key: ad8b2934-1812-4d44-b6de-3ec7f91b3c34

Device Description

IntraSpin Rotor, 110v & 220v

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	864.9245	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37530	Centrifuge rotor, ultracentrifuge	A device, commonly called the rotor, or rotor head, used as a component in an ultra centrifuge. It is designed to function safely under the centrifugal conditions created by the operational speeds. It is horizontally attached at the top of the vertical shaft which is part of the electrically-powered drive unit and the samples to be centrifuged are placed in this rotor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847236015886	GS1

Premarket Submissions

Submission Number	Supplement Number
BK120048	0