Surgical Direct

Basic Information

• Brand Name: Surgical Direct
• Primary DI: B382SDM196000
• Version / Model: SDM19600
• Catalog Number: SDM19600
• Company Name: Surgical Direct, Inc.
• Labeler DUNS: 124367223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-03
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 3528225d-4924-43fc-a482-c0ae117a0f3c

Device Description

Bending Bolt for Kirschner Wires

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
JEX	PLIER, ORTHODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33394	ENT wire-cutting scissors	A hand-held manual surgical instrument designed to cut wire intended to construct ossicular replacements for the middle ear. The cutting blades will be more robust than ordinary scissors to tolerate the forces required to cut surgical wire. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B382SDM196000	HIBCC

Customer Contacts

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