Surgical Direct

Basic Information

• Brand Name: Surgical Direct
• Primary DI: B382SD902973000
• Version / Model: SD90297300
• Catalog Number: SD90297300
• Company Name: Surgical Direct, Inc.
• Labeler DUNS: 124367223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-13
• Public Version: 2
• Public Version Date: 2024-04-17
• Public Version Status: Update
• Public Device Record Key: bac163e6-8202-4ac0-b17d-3a01e0ffd6e1

Device Description

Classic-Round Probe Periodontal Se Color Coded Fig 12

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
EIX	Probe, Periodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35942	Phosphorescent/fibreoptic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It uses a fibreoptic probe that includes a small mass temperature sensor, usually based on phosphor fluorescence decay time or other temperature varying physical property, e.g., liquid crystal structure or polarization rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B382SD902973000	HIBCC

Customer Contacts

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