ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950026401
• Version / Model: 90700100
• Catalog Number: 90700100
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Labeler DUNS: 042763706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-13
• Public Version: 1
• Public Version Date: 2019-10-21
• Public Version Status: New
• Public Device Record Key: e4df2336-55ce-420a-a016-8ce78c0fd202

Device Description

BUR DIAMOND ROUND 70MM 2.5HD HANDPIECE

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: No
• 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
EJL	BUR, DENTAL	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34816	Diamond dental laboratory bur	A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental laboratory handpiece that provides the rotation and that is intended for dental laboratory use only to cut hard structures, e.g., hard materials, plastics, porcelains and similar materials, during the fabrication of dental restorations. The diamond coating may be bonded to the different shaped bur heads by, e.g., electroplating, sintering, or moulded in various shapes with a rubber binding material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00614950026401	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.5	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No special storage conditions required