Biomet Biologics

Basic Information

• Brand Name: Biomet Biologics
• Primary DI: 00815634020788
• Version / Model: 800-0211
• Company Name: Micromedics, Inc.
• Labeler DUNS: 066839630
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-05
• Public Version: 1
• Public Version Date: 2023-12-13
• Public Version Status: New
• Public Device Record Key: fe9c7847-bb47-40ef-93ba-6158c65e1405

Device Description

Biomet Biologics Regulator

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: Yes
• 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
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47860	Surgical air pipeline regulator	A reduction valve designed to lower high and variable gas pressure in a pipeline intended for surgical applications (e.g., to drive surgical power tools) to a lower and constant working pressure, typically 3 - 12 bar. It consists of a housing containing a single- or dual-stage regulator used to regulate the surgical air, connectors (these may be permanent or quick connectors), and a pressure gauge; it may include an integral filter to remove possible contaminants, sometimes with a glass bowl for the collection of oil deposits and for observation. It is typically made of metal and synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815634020788	GS1