SHARD

Basic Information

• Brand Name: SHARD
• Primary DI: 00814639025682
• Version / Model: A600-M6-BH
• Catalog Number: A600-M6-BH
• Company Name: APPLIED DENTAL, INC.
• Labeler DUNS: 017524666
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-20
• Public Version: 1
• Public Version Date: 2022-05-30
• Public Version Status: New
• Public Device Record Key: bf607b71-1eff-49fa-b72d-0b12b7f0f2a9

Device Description

Reusable Handle of Surgical Chisel Blades for Size M31-M69. Stainless Steel, Autoclavable.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: Yes
• 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35139	Chisel/osteotome blade handle	A hand-held manual surgical device that is an interchangeable component of a chisel or osteotome blade and that functions as a handle designed to mount a compatible blade of these types which is locked into place. Together, this device and the selected blade, become a single-bladed surgical instrument used by a physician for cutting/contouring bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814639025682	GS1

Customer Contacts

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