Renfu

FDA UDI

by Guangzhou Renfu Medical Equipment Co., Ltd.

Identity

Trade Name: RENFU FDA UDI
Generic Name: Patient positioner base plate FDA UDI
Device Name: A device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device. FDA UDI
Model / Reference: MC-BF003 FDA UDI
Description: A device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device. FDA UDI

Identifiers

Catalog Number: IWY FDA UDI
Primary DI / UDI-DI: 06959931602248 FDA UDI
GMDN Term: Patient positioner base plate FDA UDI

Classification

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

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Patient positioner base plate

Renfu by Guangzhou Renfu Medical Equipment Co., Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Alta — Qfix · Class II
MR Posi-S™ Adapter — Medtec LLC · Class II
Uni-frame® Baseplate — Medtec LLC · Class II
Prone Head Holder — Medtec LLC · Class I

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	N/A	Pending data

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Manufacturer

Manufacturer: Guangzhou Renfu Medical Equipment Co., Ltd.

Sources (1)

FDA UDI bea2d8ed-c354-4f4e-9664-5ecf01891395 35 fields · synced Jun 1, 2026