FDA.reportPublic FDA data

Orfit Industries

Primary DI
05420028700396
Brand
Orfit Industries
Company
Orfit Industries NV
Model
32070/17
Device description
2-Pin Bar for Sagittilt on Varian IGRT table MRI Compatible - 53cm wide
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
K141787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141787000SAGITTILTOrfit Industries NV2014-08-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420028700396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420028700396054200287003965420028700396

GMDN Terms#

Term, Definition table
TermDefinition
DNA-based tissue typing IVD, reagentA reagent which is intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers from the major histocompatibility complex (MHC) family of genes. Genetic markers may include HLA-A, HLA-B, HLA-C, DRB1, DRB3, DRB4, DRB5, DQB1, DPB1, MICA and/or C4.

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
05401172018216Orfit35674/102026-04-15
05401172018278Orfit35675/102026-04-15
05401172036203HP PRO Positioning Device25000/892026-04-15
05401172037200Orfit324722026-04-15
05401172037217Orfit324732026-04-15
05401172037224Orfit324742026-04-15
05401172037231Orfit324752026-04-15
05401172037279Orfit327002026-04-15
05401172037286Orfit327032026-04-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700506Gold AnchorNaslund Medical ABIYE2023-01-23
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07340145701220Gold AnchorNaslund Medical ABIYE2023-01-23
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B887001067X-MARK UltraIzi Medical Products, LLCIYE2022-07-18
B8870010010X-MARKIzi Medical Products, LLCIYE2022-06-17
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B8870010030X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010070X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010080X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010090X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010210X-MARKIzi Medical Products, LLCIYE2022-06-17
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B8870010230X-MARKIzi Medical Products, LLCIYE2022-06-17