FDA.reportPublic FDA data

DORO® CereTom Horseshoe

Primary DI
04250435504086
Brand
DORO® CereTom Horseshoe
Company
Black Forest Medical GmbH
Model
4002-30
Device description
DORO® CereTom IntraOp Horseshoe Comfort Headrest, Adult
Published
2016-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K032331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032331000DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)Pro-Med Instruments GmbH2003-11-20HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250435504086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250435504086042504355040864250435504086

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
Serial number
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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