FDA.reportPublic FDA data

DORO® Extensionbar Horseshoe

Primary DI
04250435501320
Brand
DORO® Extensionbar Horseshoe
Company
Black Forest Medical GmbH
Model
3009-25
Device description
DORO® Extensionbar Horseshoe incl. Screw
Published
2024-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HBLHolder, Head, Neurosurgical (Skull Clamp)
HBMHeadrest, Neurosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2
HBMHeadrest, NeurosurgicalNeurology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001808000DORO HEADREST SYSTEMPro-Med Instruments GmbH2000-08-04HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250435501320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250435501320042504355013204250435501320

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
313517922
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250435500026DORO® Base Unit3001-001 2016-12-15
04250435500149DORO® Base Unit3001-0102016-12-15
04250435503058DORO® Blade3116-111 2016-12-09
04250435503072DORO® Blade3116-121 2016-12-09
04250435503096DORO® Blade3116-131 2016-12-09
04250435503119DORO® Blade3116-1412016-12-09
04250435503133DORO® Blade3116-151 2016-12-09
04250435503157DORO® Blade3116-1612016-12-09
04250435503454DORO® Blade3116-611 2016-12-09
04250435503478DORO® Blade3116-621 2016-12-09
04250435503492DORO® Blade3116-631 2016-12-09
04250435529867DORO LUCENT® iMRI Transfer Collision Indicator 4003.4132025-02-10
04250435539378DORO® LUCENT iMRI Coil Connector IMRIS4003.6312023-10-25
04250435502297DORO® Torque Screwdriver3034-122021-04-06
04250435536117DORO LUCENT® iMRI Transfer Collision Indicator 4003.533 2021-03-12
04250435519394DORO® Skull Clamp3020-502020-11-18
04250435500019DORO® Base Unit3001-002016-12-15
04250435500057DORO® Base Unit3001-002 2016-12-15
04250435500095DORO® Base Unit3001-0062016-12-15
04250435500125DORO® Base Unit3001-009 2016-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10381780256113MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
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10381780256144MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
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10381780256175MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
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10381780256199MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256205MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256212MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256229MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256236MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256243MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256250MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256267MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256274MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256281MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256687MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780025757MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025764MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025771MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025788MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025795MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
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10381780253334MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253341MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253358MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253365MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253372MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26