Question 1

What types of medical devices does SBH Surgical manufacture?

Accepted Answer

SBH Surgical produces a range of reusable and single-use surgical instruments. Their portfolio includes sterilization/disinfection containers for reusable devices, nail clippers designed for single-use, neurosurgical headrests, spinal rongeurs, and alligator-style soft-tissue manipulation forceps. They also manufacture electrosurgical handpieces/electrode holders (single-use), skull clamps, and skull clamp pins (reusable), primarily for neurosurgical and spinal procedures. The company focuses on instruments that support precision and sterility in operating environments.

Question 2

Where is SBH Surgical based, and does this affect its regulatory compliance?

Accepted Answer

SBH Surgical is based in the United States. As a US-based manufacturer, its devices must comply with FDA regulations, including classification under FDA’s device categories (Class I or Class II) and participation in the FDA’s Unique Device Identification (UDI) system. The company adheres to domestic regulatory requirements applicable to its products, ensuring alignment with US medical device standards.

Question 3

Which regulatory registries or databases list SBH Surgical’s devices?

Accepted Answer

SBH Surgical’s devices are listed in the FDA’s Unique Device Identification (UDI) system. The UDI system assigns a unique identifier to each device to improve tracking, transparency, and post-market surveillance. This listing helps healthcare providers, regulators, and other stakeholders verify and monitor the devices in use.

Question 4

How are SBH Surgical’s devices classified under FDA regulations?

Accepted Answer

SBH Surgical’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in FDA’s regulatory framework.

Device	Model / Reference	Registries	Class	Status
Sbh	SB 100.040E - Blue Lid	FDA UDI	Class II	Active
Sbh	SB 106.100E Non Perforated Bottom	FDA UDI	Class II	Active
Sbh	MF - Swivel Adaptor	FDA UDI	Class I	Active
Sbh	Single Use - SBH 636560	FDA UDI	Class I	Active
Sbh	MF - Skull Pins	FDA UDI	Class I	Active
Sbh	Single Use - 75470-11S	FDA UDI	Class I	Active
Sbh	Dental - 506.080E	FDA UDI	Class II	Active
Sbh	Chroma - Blue 3mm	FDA UDI	Class I	Active
Sbh	ER504.040E - Blue Lid	FDA UDI	Class II	Active
Sbh	MF - Skull Clamp	FDA UDI	Class I	Active
Sbh	ER500.040E - Lid Perforated	FDA UDI	Class II	Active
Sbh	SB 106.135E - Non Perforated Bot.	FDA UDI	Class II	Active
Sbh	Single Use - 75620-15S	FDA UDI	Class I	Active
Sbh	MF - System	FDA UDI	Class I	Active
Sbh	Single Use - 4311227	FDA UDI	Class I	Active
Sbh	Single Use	FDA UDI	Class II	Active
Sbh	Single Use - 75480-13S	FDA UDI	Class I	Active
Sbh	K123234	FDA UDI	Class II	Active
Sbh	Single Use - SB 940250	FDA UDI	Class I	Active
Sbh	ER505.040E Non Perforated Bottom	FDA UDI	Class II	Active
Sbh	Single Use - 875470	FDA UDI	Class I	Active
Sbh	Single Use - 3721036-S	FDA UDI	Class I	Active
Sbh	ER505.050E Non Perforated Bottom	FDA UDI	Class II	Active
Sbh	Single Use - 75618-15S	FDA UDI	Class I	Active
Sbh	MF - Adjustable Base	FDA UDI	Class I	Active
Sbh	Chroma - Blue 2mm	FDA UDI	Class I	Active

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