Dalbo®-PLUS

Basic Information

• Brand Name: Dalbo®-PLUS
• Primary DI: 07640166511403
• Version / Model: 05001240
• Catalog Number: 05001240
• Company Name: Cendres+Métaux SA
• Labeler DUNS: 487506230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 2
• Public Version Date: 2021-06-11
• Public Version Status: Update
• Public Device Record Key: db30052d-0550-4bfe-82d3-4afc15987264

Device Description

Dalbo®-PLUS Female Part Basic

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: Yes
• 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
EJX	Anchor, Preformed	Dental	872.3130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46307	Dental anchor	A device made of austenitic alloys or alloys containing 75 percent or greater gold (Au) or metals of the platinum group, intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640166511403	GS1

Customer Contacts

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

Storage Conditions

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