Stitching Platform with Handles/ Clear Stitching Stand

FDA UDI

Class I (US FDA UDI)

by Reina Imaging

Identity

Trade Name: Stitching Platform with Handles/ Clear Stitching Stand FDA UDI
Generic Name: Radiological general body-part positioner FDA UDI
Device Name: Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping platform for the patient and a clear polycarbonate back that allows a radiology technologist to position the device centered to the image receptor, facilitating patient positioning. FDA UDI
Model / Reference: CSS[X]; SPH-F FDA UDI
Description: Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping platform for the patient and a clear polycarbonate back that allows a radiology technologist to position the device centered to the image receptor, facilitating patient positioning. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860001700169 FDA UDI
FDA Product Code: KXH FDA UDI
GMDN Term: Radiological general body-part 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological general body-part positioner

Stitching Platform with Handles/ Clear Stitching Stand by Reina Imaging — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Reina Imaging

Sources (1)

FDA UDI bd52daa9-d7c7-4d34-a2e0-75892f0a4544 34 fields · synced May 31, 2026