devemed

Basic Information

• Brand Name: devemed
• Primary DI: 04061644017102
• Version / Model: 2409
• Company Name: devemed GmbH
• Labeler DUNS: 506826739
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-17
• Public Version: 1
• Public Version Date: 2020-04-27
• Public Version Status: New
• Public Device Record Key: d6fabf6c-d036-481c-868f-40e1eacac95f

Device Description

Bone aspirator for collection of osseous material, incl. filter Ø 9 mm front: Ø 4.0/3.0mm; back: Ø 6.0/5.0mm

Device Characteristics

• Single Use: No
• 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
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44888	Dental bone particle collector	A small container designed as a bone-harvesting device (bone trap) to collect autologous bone fragments, e.g., when drilling in the jawbone during a dental implant surgical procedure. It functions as a filter that traps the bone particles and is typically placed in a suction tube line between the site of operation and the suction unit. The harvested bone particles may be saved for future use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04061644017102	GS1

Customer Contacts

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