Bone Caliper

Basic Information

• Brand Name: Bone Caliper
• Primary DI: 00083208130106
• Version / Model: Bone Caliper
• Catalog Number: Bone Caliper
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-03
• Public Version: 1
• Public Version Date: 2021-02-11
• Public Version Status: New
• Public Device Record Key: 6261792b-ec2b-427d-9633-9b3d59bea343

Device Description

Bone caliper is used during surgery to determine/confirm the width and or other dimensions of bone, in millimeters, that is available for Implant placement

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
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35788	Orthopaedic bone calliper	A hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208130106	GS1

Customer Contacts

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