FDA.reportPublic FDA data

iFIX

Primary DI
09010279001708
Brand
iFIX
Company
iSYS Medizintechnik GmbH
Model
iFIX Side Rail Adapter US
Catalog number
42642-US
Device description
Designed for connection with operating tables, contains a side-rail adapter portion (to fit US side-rails) and a flat plastic portion to which a standard iFIX Patch with custom size is attached. Ideal for interventions and surgery, where tables often exhibit a side-rail at different patient heights and allow a strong and clean fixation of equipment, including the iFIX Side-Rail Adapter.
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FMQRestraint, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
29010279001702PackageGS14In Commercial Distribution
09010279001708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2901027900170229010279001702
09010279001708090102790017089010279001708

GMDN Terms#

Term, Definition table
TermDefinition
Medical table restraint anchorA device intended to be fixed to an operating/radiological table to provide a firmly secure point of attachment for a non-rigid restraint (e.g., strap, band, fabric sheet) to help achieve patient positioning and stabilization during a medical procedure. It may be in the form of a piece of flat material with double-sided adhesive, or a rigid sliding pad/plate that is attached to or fits into a matching slot on the medical table or table rails. Disposable positioners/restraints may be included with the device. This is a reusable device.

Regulatory Flags#

DUNS number
300207996
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09010279001548Micromate Navi+iONE2024-02-26
09010279000411MicromateiONE2023-09-06
09010279001715iFIXiFIX Side Rail Adapter JP42642-JP2024-07-30
09010279001050iFIXiFIX Arm Rest Tray558072024-07-30
09010279001289iFIXiFIX Canon Aquilion Adapter546312024-07-30
29010279001702iFIXiFIX Side Rail Adapter US42642-US2024-07-30
29010279001719iFIXiFIX Side Rail Adapter JP42642-JP2024-07-30
09010279001142iFIXHead Kit MRI GE587812021-07-01
09010279001128iFIXHead Kit Angio587792021-07-01
09010279001135iFIXHead Kit CT587802021-07-01
09010279001159iFIXThorax Kit CT Canon587872021-07-01
09010279001166iFIXThorax Kit CT Siemens587882021-07-01
09010279001173iFIXKit CT Micromate BP587862021-07-01
09010279001180iFIXThorax Kit CT GE587892021-07-01
09010279001197iFIXThorax Kit MRI Philips587912021-07-01
09010279001203iFIXThorax Kit MRI Siemens587922021-07-01
09010279001210iFIXThorax Kit MRI GE587932021-07-01
09010279001227iFIXArm Stabilization Kit587962021-07-01
09010279001234iFIXSpine Surgery Kit587982021-07-01
09010279001241iFIXHead Kit MRI589322021-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196310128MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-06-03
10748426141125Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10080196281374MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
10810087352766CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353039CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353060CoulmedCoulmed Products Group LLCFMQ2023-01-06
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10190676002556POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
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10190676002570POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002594POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002600POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
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