SBH

Basic Information

• Brand Name: SBH
• Primary DI: 00850068304196
• Version / Model: MF - Skull Pins
• Catalog Number: SBH 117-000-54
• Company Name: SBH Surgical
• Labeler DUNS: 096823436
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-03
• Public Version: 1
• Public Version Date: 2024-12-11
• Public Version Status: New
• Public Device Record Key: 79d5fb7b-e8b6-4846-8788-94fbecb070a7

Device Description

MF-Skull Pins, Titanium, Reusable, Adults

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HBM	Headrest, Neurosurgical	Neurology	882.4440	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65606	Skull clamp pin, reusable	An invasive rod designed to be attached to a skull clamp (not included) to secure the skull clamp to the patient’s skull by penetrating the outer bone of the skull during a surgical procedure; three pins are typically required. It is typically made of high-grade surgical stainless steel, silicone, or titanium (Ti). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850068304196	GS1

Customer Contacts

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