FDA.reportPublic FDA data

Reinforcement-Arm

Primary DI
04251554151502
Brand
Reinforcement-Arm
Company
medical bees GmbH
Model
MB2-20-402-00
Catalog number
MB2-20-402-00
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04251554151502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251554151502042515541515024251554151502

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

Regulatory Flags#

DUNS number
342619239
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251554151991SL-Lateral Muscle Blade 50 mm short teeth, anodised dark violet MB1-10-852-502026-05-21
04251554122335Caspar screwdriver with black wheel handle (PPSU) 20 x 16 mm MB1-10-746-232026-05-19
04251554122403Spinal retractor Caspar drill long Drill length 14 mm, shaft Ø 8 mm Total lengthMB1-10-748-022026-05-19
04251554128689Depth Gauge Colour CodedMB1-10-860-602026-05-19
04251554135304Caliper Measuring range 160mm 47/100mmMB1-20-028-202026-05-19
04251554151809Bone graft forceps tip 7mmMB1-10-850-302026-05-19
04251554151816Bone graft holder total length 21.6cmMB1-10-850-402026-05-19
04251554151823Bone tamper Ø3mmMB1-10-851-032026-05-19
04251554151830Bone tamper Ø5mmMB1-10-851-052026-05-19
04251554151847Bone tamper Ø8mmMB1-10-851-082026-05-19
04251554151854SL Tissue Blade 30 mm blunt silver, anodised natural MB1-10-851-302026-05-19
04251554151861SL Tissue Blade 35mm blunt anodised dark blueMB1-10-851-352026-05-19
04251554151878SL Tissue Blade 40 mm blunt anodised dark red MB1-10-851-402026-05-19
04251554151885SL Tissue Blade 50 mm anodised dark violetMB1-10-851-502026-05-19
04251554151892SL Tissue Blade 55 mm blunt anodised black MB1-10-851-552026-05-19
04251554151908SL Tissue Blade 45 mm blunt anodised olive-green MB1-10-851-452026-05-19
04251554151915SL Tissue Blade 60 mm blunt anodised dark goldMB1-10-851-602026-05-19
04251554151922SL Tissue Blade 65 mm blunt anodised titanium MB1-10-851-652026-05-19
04251554151939SL Tissue Blade 70 mm blunt anodised yellow MB1-10-851-702026-05-19
04251554151946SL Tissue Blade 75 mm blunt anodised dark orange MB1-10-851-752026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995244996NASTERIS CORPORATIONHBM2025-05-05
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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
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
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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
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