FDA.reportPublic FDA data

DORO® LUCENT iMRI Interface Adaptor IMRIS

Primary DI
04250435539521
Brand
DORO® LUCENT iMRI Interface Adaptor IMRIS
Company
Black Forest Medical GmbH
Model
4003.611
Device description
DORO® LUCENT iMRI Interface Adaptor IMRIS
Published
2023-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
HBMHeadrest, Neurosurgical
JEATable, Surgical With Orthopedic Accessories, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBMHeadrest, NeurosurgicalNeurology1
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250435539521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250435539521042504355395214250435539521

GMDN Terms#

Term, Definition table
TermDefinition
Medical table clampA device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313517922
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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

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00840343726720FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726737FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726744FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726751FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726768FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00840343726775FusionMAXSURGIX MEDICAL LLCJEA2025-09-10
00842430109294ADANTE SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109300ADANTE EXTENDED SADDLE POSTMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109317ADANTE TRACTION BOOT, SMALL, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109324ADANTE TRACTION BOOT, LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430109331ADANTE TRACTION BOOT, EX LARGE, PAIRMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116605Adante Femoral Hook BracketMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430116612Adante Knee Foot SupportMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117008Adante IntelliTouch Hand PendantMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117022Adante Traction Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117039Adante Traction Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117046Adante Pelvic Center BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117053Adante Knee Extension BoardMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117084Adante Knee Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117091Adante Knee Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117107Adante FlexLation Spar, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117114Adante FlexLation Spar, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117121Adante AX Orthopedic Surgical PlatformMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117138Adante Knee Pad Support Mount, RightMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117145Adante Knee Pad Support Mount, LeftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117152Adante Femur LiftMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117169Adante Wireless Foot PedalMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04
00842430117176Adante Supine Perineal PostMIZUHO ORTHOPEDIC SYSTEMS, INC.JEA2025-07-04