FDA.report

Orfit Industries

Primary DI
05420028774243
Brand
Orfit Industries
Company
Orfit Industries NV
Model
29111-P
Device description
MRI-P Solution Head, Neck & Shoulders
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IYEAccelerator, linear, medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05420028774243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05420028774243054200287742435420028774243

GMDN Terms

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

Contacts

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 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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