Capseus Surgical

Basic Information

• Brand Name: Capseus Surgical
• Primary DI: 10665973027118
• Version / Model: BDC-15
• Catalog Number: BDC-15
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-23
• Public Version: 3
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: 8361e694-f717-4ade-bc0c-8adcf62ce837

Device Description

Bone Dust Collector - 9646

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
GCX	APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44816	Bone dust vacuum system	An assembly of devices used to collect bone dust from the workspace environment by suction, typically during autopsy sawing procedures. It generally consists of a mains electricity (AC-powered) vacuum motor, tubing, collection container, and a filter. The proximal end of the vacuum tubing will typically attach to the saw, and the vacuum motor may automatically run concurrently with the saw motor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30665973027112	GS1	Case	4	In Commercial Distribution
Package	20665973027115	GS1	Box	5	In Commercial Distribution
Primary	10665973027118	GS1

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]