FDA.reportPublic FDA data

SBH

Primary DI
00850068304165
Brand
SBH
Company
SBH Surgical
Model
MF - Swivel Adaptor
Catalog number
SBH 117-000-25
Device description
MF-Swivel Adaptor
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
00850068304165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850068304165008500683041658500683041650850068304165

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical headrestA device designed to be attached to an appropriate operating table to support and immobilize the head of a recumbent patient during a neurosurgical procedure. The headrest is typically made of metal and synthetic materials that incorporate a semicircular cupped cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustment to facilitate surgeon access to the skull. This device may be attached to dedicated chairs used for neurosurgical procedures. 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
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
00850068304172SBHSBH SurgicalHBM2024-12-06
00850068304158SBHSBH 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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00883475954685Vertical Post UprightCHARMANT INC.HBM2023-09-18
00883475954692Fukushima Universal Holding SystemCHARMANT INC.HBM2023-09-18