FDA.reportPublic FDA data

SBH

Primary DI
00850068304172
Brand
SBH
Company
SBH Surgical
Model
MF - Skull Clamp
Catalog number
SBH 117-000-40
Device description
MF-Skull Clamp
Published
2024-12-06
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
00850068304172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068304172008500683041728500683041720850068304172

GMDN Terms#

Term, Definition table
TermDefinition
Skull clampA U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints (either incorporated or separate) for positioning/stabilization; it is not intended for applying traction forces to the cervical spine. 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
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
00850068304196SBHMF - Skull PinsSBH 117-000-54 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
00850068304158SBHSBH SurgicalHBM2024-12-03
00850068304165SBHSBH SurgicalHBM2024-12-03
00850068304189SBHSBH SurgicalHBM2024-12-03
00850068304196SBHSBH 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
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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