FDA.reportPublic FDA data

SBH

Primary DI
00850068304196
Brand
SBH
Company
SBH Surgical
Model
MF - Skull Pins
Catalog number
SBH 117-000-54
Device description
MF-Skull Pins, Titanium, Reusable, Adults
Published
2024-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBMHeadrest, Neurosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBMHeadrest, NeurosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850068304196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068304196008500683041968500683041960850068304196

GMDN Terms#

Term, Definition table
TermDefinition
Skull clamp pin, reusableAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9493053300miguel@sbhsurgical.com

Regulatory Flags#

DUNS number
096823436
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850068304424SBHBariatric Table ClampBT012026-05-11
00850068304431SBHBariatric Cross BarB022026-05-11
00850068304448SBH"Bariatric Cross Bar 1/2"""G2W4271-83F2026-05-11
00850068304851SBHTrachea Hook ReusableSBH 55120-152026-05-08
00850068304226SBHChroma - Blue 2mmG2W4271-82F 2025-08-11
00850068304233SBHChroma - Blue 3mmG2W4271-83F2025-08-11
00850068304257SBHER505.040E Non Perforated BottomER505.040E2025-06-16
00850068304264SBHER500.040E - Lid PerforatedER500.040E2025-06-16
00850068304271SBHER504.040E - Blue LidER504.040E 2025-06-16
00850068304288SBHER505.050E Non Perforated BottomER505.050E2025-06-16
00850068304240SBHSB 100.040E - Blue LidSB 100.040E2025-02-26
00850068304202SBHSB 106.100E Non Perforated BottomSB 106.100E2025-02-20
00850068304219SBHSB 106.135E - Non Perforated Bot.SB 106.135E2025-02-20
00850068304172SBHMF - Skull ClampSBH 117-000-402024-12-06
00850068304158SBHMF - Adjustable BaseSBH 117-000-15 2024-12-03
00850068304165SBHMF - Swivel AdaptorSBH 117-000-25 2024-12-03
00850068304189SBHMF - SystemSBH 117-000-10 2024-12-03
00850068304004SBHDental - 506.080ESB 506.080E2024-10-04
00850068304028SBHSingle Use - SBH 636560SBH 6365602024-10-04
00850068304035SBHSingle Use - 4311227SBH 43112272024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995244996NASTERIS CORPORATIONHBM2025-05-05
00724995244910NASTERIS CORPORATIONHBM2025-05-05
04250435529867DORO LUCENT® iMRI Transfer Collision Indicator Black Forest Medical GmbHHBM2025-02-10
00850068304172SBHSBH SurgicalHBM2024-12-06
00850068304158SBHSBH SurgicalHBM2024-12-03
00850068304165SBHSBH SurgicalHBM2024-12-03
00850068304189SBHSBH SurgicalHBM2024-12-03
00724995229290NASTERIS CORPORATIONHBM2024-11-25
00857534006837Horseshoe HeadrestIMRIS Imaging, Inc.HBM2024-11-01
00857534006844Horseshoe HeadrestIMRIS Imaging, Inc.HBM2024-11-01
04251554151502Reinforcement-Armmedical bees GmbHHBM2024-10-14
04250435501320DORO® Extensionbar Horseshoe Black Forest Medical GmbHHBM2024-07-11
00724995229160NASTERIS CORPORATIONHBM2024-03-08
00724995229177NASTERIS CORPORATIONHBM2024-03-08
00724995229184NASTERIS CORPORATIONHBM2024-03-08
00724995229191NASTERIS CORPORATIONHBM2024-03-08
00724995229207NASTERIS CORPORATIONHBM2024-03-08
00724995229214NASTERIS CORPORATIONHBM2024-03-08
00724995177782NASTERISHBM2023-12-11
04250435539378DORO® LUCENT iMRI Coil Connector IMRISBlack Forest Medical GmbHHBM2023-10-25
04250435539521DORO® LUCENT iMRI Interface Adaptor IMRISBlack Forest Medical GmbHHBM2023-10-25
00883475951172Fukushima Universal Holding SystemCHARMANT INC.HBM2023-09-18
00883475954623Mini C ClampCHARMANT INC.HBM2023-09-18
00883475954630Table ClampCHARMANT INC.HBM2023-09-18
00883475954647Tightening DriverCHARMANT INC.HBM2023-09-18
00883475954654U-Bar DistalCHARMANT INC.HBM2023-09-18
00883475954661U-Bar ProximalCHARMANT INC.HBM2023-09-18
00883475954678Vertical Post TiltedCHARMANT INC.HBM2023-09-18
00883475954685Vertical Post UprightCHARMANT INC.HBM2023-09-18
00883475954692Fukushima Universal Holding SystemCHARMANT INC.HBM2023-09-18