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Orfit Industries

FDA UDI

Class II (US FDA UDI)

by Orfit Industries NV

Identity

Trade Name
Orfit Industries FDA UDI
Generic Name
DNA-based tissue typing IVD, reagent FDA UDI
Device Name
MD Head Support - Model 7 Asian Version For other hardware FDA UDI
Model / Reference
32426-MD FDA UDI
Description
MD Head Support - Model 7 Asian Version For other hardware FDA UDI

Identifiers

Primary DI / UDI-DI
05420028777503 FDA UDI
510(k) Number
K991319 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
DNA-based tissue typing IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: DNA-based tissue typing IVD, reagent

Orfit Industries' MD Head Support - Model 7 Asian Version is a reliable and accurate MRI-compatible head support device designed to ensure patient safety during MRI procedures. This device features MR Safe certification, making it an ideal solution for medical institutions seeking to improve MRI safety standards.

Similar devices

Also classified as DNA-based tissue typing IVD, reagent.

Cleared under the same submission

K991319 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orfit Industries NV

Sources (1)

  • FDA UDI 623508ce-dc65-4391-b8f9-2dfb0ca318b6 35 fields · synced Jul 21, 2026