Orfit Industries

Basic Information

• Brand Name: Orfit Industries
• Primary DI: 05420028708293
• Version / Model: 35704/MR
• Company Name: Orfit Industries NV
• Labeler DUNS: 283679900
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-17
• Public Version: 1
• Public Version Date: 2022-11-25
• Public Version Status: New
• Public Device Record Key: 5e315c1f-68d9-406e-a19f-dd3dbe077fc6

Device Description

Wedge 9° angle in Fibreglass - MRI Compatible

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, linear, medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60119	DNA-based tissue typing IVD, reagent	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05420028708293	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991319	000