Orfit Industries

Primary DI
05420028716632
Brand
Orfit Industries
Company
Orfit Industries NV
Model
32827
Device description
Aerial Couch Top for IBA + Forte
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, linear, medical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200282000Orfit Aerial CouchtopOrfit Industries NV2020-04-08LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420028716632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420028716632054200287166325420028716632

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05401172003861Orfit321082026-04-15
05401172011170The AIO Solution32006-V22026-04-15
05401172011439The AIO Solution32015/82026-04-15
05401172011477The AIO Solution32015/92026-04-15
05401172011491The AIO Solution32015/9/12026-04-15
05401172011514The AIO Solution32015/9/22026-04-15
05401172011552The AIO Solution32015/9/32026-04-15
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05401172036203HP PRO Positioning Device25000/892026-04-15
05401172037200Orfit324722026-04-15
05401172037217Orfit324732026-04-15
05401172037224Orfit324742026-04-15
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05401172037279Orfit327002026-04-15
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05401172037460Efficast45206/2MA2026-04-15
05401172037866Efficast/Nanor Hybrid33730/2MA/12ML+N2026-04-15
05401172038108Efficast/Nanor Hybrid33804/2MA/12MI+N2026-04-15
05401172039495SBRT32110/12/INTERN2026-04-15

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