Orfit Industries

FDA UDI

Class II (US FDA UDI)

by Orfit Industries NV

Identity

Trade Name: Orfit Industries FDA UDI
Generic Name: Head/neck procedure positioner FDA UDI
Device Name: 10 (pcs.) Bags for Thermofit 32392 FDA UDI
Model / Reference: 32406/10 FDA UDI
Description: 10 (pcs.) Bags for Thermofit 32392 FDA UDI

Identifiers

Primary DI / UDI-DI: 05420028705278 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Head/neck procedure positioner 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Head/neck procedure positioner

Orfit Industries is a high-quality, noninvasive head/neck procedure positioner designed to provide optimal support and positioning for patients undergoing intraoperative or diagnostic imaging procedures. This reusable device features adjustable elements, a sturdy frame, and a compact design making it suitable for various medical specialties. With its precise height and angle adjustment capabilities, Orfit Industries is an essential tool in the operating room.

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Target Positioner — Brainlab SE · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orfit Industries NV

Sources (1)

FDA UDI 5ccde092-a934-4ef2-9762-97f88f2e40c3 34 fields · synced Jul 18, 2026