Small U Head Cushions

FDA UDI

Class I (US FDA UDI)

by Octostop Inc

Identity

Trade Name: Small U Head Cushions FDA UDI
Generic Name: Radiological whole-body positioner FDA UDI
Model / Reference: CO-02 FDA UDI

Identifiers

Primary DI / UDI-DI: B525CO020 FDA UDI
FDA Product Code: KXH FDA UDI
GMDN Term: Radiological whole-body positioner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1830 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological whole-body positioner

Small U Head Cushions by Octostop Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Radiological whole-body positioner.

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iCAST H&S Micro 2mm — IT-V Medizintechnik GmbH · Class II
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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 I	Pending data

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Manufacturer

Manufacturer: Octostop Inc

Sources (1)

FDA UDI d67123dd-75c4-4330-93b9-0d6c42c9aa56 32 fields · synced May 30, 2026