DORO® Reusable Skull Pins

Basic Information

• Brand Name: DORO® Reusable Skull Pins
• Primary DI: 04250435501047
• Version / Model: 3004-00
• Company Name: Black Forest Medical GmbH
• Labeler DUNS: 313517922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 7
• Public Version Date: 2026-01-06
• Public Version Status: Update
• Public Device Record Key: b2e33390-fb89-4c8c-83ef-87ea8255a9f8

Device Description

DORO® Reusable Skull Pins Stainless Steel, Pediatric (3 pcs)

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: No
• 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
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	882.4460	2

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	04250435501047	GS1

Premarket Submissions

Submission Number	Supplement Number
K001808	000