FDA.reportPublic FDA data

Orfit Industries

Primary DI
05420028710227
Brand
Orfit Industries
Company
Orfit Industries NV
Model
33735/16MI/12MI+N
Device description
5pt Hybrid HNS Open Face and Neck Mask Eff 16MI - Nanor 12MI+
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

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
K131795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131795000NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALSOrfit Industries NV2013-09-26IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420028710227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420028710227054200287102275420028710227

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

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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00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
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00850065937304eMotusEMPNIA INC.IYE2026-09-21