N/a

Basic Information

• Brand Name: N/a
• Primary DI: 07613327502985
• Version / Model: 5400-800-000
• Catalog Number: 5400-800-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-12
• Public Version: 1
• Public Version Date: 2020-06-22
• Public Version Status: New
• Public Device Record Key: a0e9dfbe-5bf0-42b0-b839-8e4ac6599d05

Device Description

Bone Vac

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: 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: 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
BYZ	TRAP, STERILE SPECIMEN	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47624	Bone graft harvesting filter	A sterile receptacle designed to collect morselized (cut/shredded into small pieces) bone and bone marrow typically obtained during an intramedullary procedure involving reaming, irrigation, and aspiration (suction). The filter is situated, with connection tubing, between the bone harvesting device (e.g., the orthopaedic reamer handpiece) and a suction system which creates vacuum to draw the graft into the filter where it is captured. The retrieved tissue is used for surgical procedures requiring bone graft (e.g., to facilitate bone fusion and/or fill bone defects). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613327502986	GS1	pack	5	In Commercial Distribution
Primary	07613327502985	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius