FILTER

Basic Information

• Brand Name: FILTER
• Primary DI: 00888118061355
• Version / Model: 38-025-01-07
• Company Name: KLS-Martin L.P.
• Labeler DUNS: 826499238
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 40fbe171-1152-4a50-a268-38fb6c1aae1d
• Distribution End Date: 2021-04-20

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MXP	BONE PARTICLE COLLECTOR	Ear, Nose, Throat	874.4800	1

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
Primary	00888118061355	GS1

Customer Contacts

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