BoneHog

Basic Information

• Brand Name: BoneHog
• Primary DI: 00810633020692
• Version / Model: LM-06
• Company Name: Biomedical Enterprises, Inc.
• Labeler DUNS: 792619009
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2020-05-07
• Public Version Status: Update
• Public Device Record Key: cca2529f-b645-4ea8-a313-7eb82fe3b417

Device Description

BoneHog 6mm Collection Chamber

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61140	Blood cell harvesting system	An assembly of non-powered sterile devices intended to be used to concentrate and collect nucleated cells, platelets, or bone marrow aspirate cells, from a volume of the patient's own blood/bone marrow, for human cell therapy. It typically includes flexible bags, tubing with slide clamps, and a filter to capture the target cells which are subsequently flushed using a harvest solution (not included) into a collection vessel. It is intended to be used at the point-of-care during a procedure, or in a laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810633020692	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: May be stored at room temperature