Hensler Bone Press

Basic Information

• Brand Name: Hensler Bone Press
• Primary DI: 00853755004003
• Version / Model: HBP
• Catalog Number: HBP-001
• Company Name: Hensler Surgical
• Labeler DUNS: 023924230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-01
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: a07b3917-da5a-4bdf-a1e7-1e81e4bdf5d5

Device Description

The Bone Press is a medical device and has been developed to maximize the collection and separation of autologous bone from blood and irrigants for bone fusion applications. No additional accessories are provided with this device outside of what is in the kit. The Hensler Bone Press (HBP) is intended for sterile, single-use with a surgical suction line to collect autologous bone or tissue particles that are utilized in bone fusion. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians.

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYZ	Trap, Sterile Specimen	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853755004003	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and away from sunlight