FDA.reportPublic FDA data

Orfit Industries

Primary DI
05420028774113
Brand
Orfit Industries
Company
Orfit Industries NV
Model
33139
Device description
AIO Anti-tilt Fixation - Bridge Bar iBeam® Couch Top - MRI compatible
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420028774113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420028774113054200287741135420028774113

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3233262026welcome@orfit.com

Regulatory Flags#

DUNS number
283679900
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420028700020Orfit Industries33702/2MA2022-12-07
05420028700099Orfit Industries331432022-12-07
05420028700105Orfit Industries331552022-12-07
05420028700273Orfit Industries331232022-12-07
05420028700297Orfit Industries33737/2MA/12MI+N/NH2022-12-07
05420028700310Orfit Industries25000/182022-12-07
05420028700327Orfit Industries25000/202022-12-07
05420028700358Orfit Industries25000/1/MR2022-12-07
05420028700365Orfit Industries25000/222022-12-07
05420028700396Orfit Industries32070/172022-12-07
05420028700419Orfit Industries331412022-12-07
05420028700433Orfit Industries331652022-12-07
05420028700457Orfit Industries331402022-12-07
05420028700464Orfit Industries331642022-12-07
05420028700501Orfit Industries331382022-12-07
05420028700518Orfit Industries331622022-12-07
05420028700525Orfit Industries331532022-12-07
05420028700570Orfit Industries331562022-12-07
05420028700792Orfit Industries32150/122022-12-07
05420028700846Orfit Industries25101/16MI+N/NH2022-12-07

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Primary DI, Brand, Company table
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00840510401054KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401061KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
00840510401078KLARITY MEDICALKlarity Medical Products, LLCIYE2026-03-12
10840277411812Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
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