DORO Sterile Disposable Skull Pins Stainless Steel, Adult - DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20)

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

DORO® Sterile Disposable Skull Pins, Stainless Steel, Pediatric (36 pcs) EUDAMED

DORO® Sterile Disposable Skull Pins GUDID

Generic Name

Skull clamp pin, single-use

Model / Reference

3006-10

FDA applicant

Pro Med Instruments GmbH

Primary DI / UDI-DI

04250435545676 EUDAMED

04250435501085 GUDID

Basic UDI-DI

42504355PA0601YS

Unit of Use DI

04250435545737

510(k) Number

K241883 ↗ 510(k)

K193438 ↗ GUDID

FDA Product Code

HBL

EMDN Code

Z12109080 Various neurology and neurosurgery instruments - hardware accessories

GMDN Term

Skull clamp pin, single-use

Models / Variants

DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)

DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10)

DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20)

DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30)

DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 882.4460

EU market of registration

Germany

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from Pro-Med Instruments GmbH →

• Are these skull pins reusable or designed for single-use, and why does that matter in surgery?

  These DORO skull pins are explicitly designed for single-use only and must be discarded after one surgical procedure. This is critical because neurosurgical procedures require strict sterility to prevent infection, and reuse could compromise the integrity of the pins or introduce contamination. The sterile packaging ensures each set is uncontaminated for one procedure, aligning with best practices for minimizing surgical risks.

• What materials are the pins made from, and how does that affect their use in adult vs. pediatric patients?

  The pins are available in stainless steel or titanium, with separate sets for adult and pediatric patients. Stainless steel is durable and cost-effective, while titanium offers lighter weight and corrosion resistance, which may be preferable for prolonged procedures or patients with metal sensitivities. The pediatric variants are sized appropriately for smaller skulls, ensuring secure fixation without excessive force.

• How are the pins packaged, and what precautions should be taken to maintain sterility before use?

  Each set of 36 pins comes in sterile packaging, which preserves their cleanliness until opening. To maintain sterility, the packaging should remain unopened until immediately before use, and the pins should only be handled with sterile instruments or gloves. Avoid exposing the pins to air currents or contaminated surfaces, as this could compromise their sterile state.

• What types of neurosurgical procedures are these pins intended for, and why are they particularly useful?

  These pins are designed for open and percutaneous craniotomies, as well as spinal surgeries requiring stable head positioning. Their purpose is to secure a skull clamp to the patient’s skull, providing rigid fixation during delicate procedures where even slight movement could risk injury. This stability is essential for precision in neurosurgery, particularly when working near critical structures like the brain or spinal cord.

• How do I know which set to order for my patient, and what size differences should I expect between adult and pediatric variants?

  The adult sets (e.g., 3006-00 or 3006-20) are sized for larger skulls, while the pediatric sets (e.g., 3006-10 or 3006-30) are smaller to accommodate children’s skulls. The exact dimensions aren’t specified here, but the key distinction is that pediatric pins are shorter/shallower to fit smaller craniums safely. Always verify the patient’s age and skull size before ordering to ensure proper fixation.