BoS™

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name: BoS™ FDA UDI
Generic Name: Patient positioner base plate FDA UDI
Device Name: BoS Headframe, Standalone, 28mm SRS Ready FDA UDI
Model / Reference: RT-4535BOSBB FDA UDI
Description: BoS Headframe, Standalone, 28mm SRS Ready FDA UDI

Identifiers

Catalog Number: RT-4535BOSBB FDA UDI
Primary DI / UDI-DI: 10841962108659 FDA UDI
FDA Product Code: JAI FDA UDI
GMDN Term: Patient positioner base plate FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5770 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient positioner base plate

BoS™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioner base plate.

Meicen — Guangdong Meicen Medical Equipment Co., Ltd. · Class I
Type-S™ Variable Axis Baseplate — Medtec LLC · Class II
Posifix® -2 Baseplate — Medtec LLC · Class II
MR Posi-S™ Adapter — Medtec LLC · Class II
Uni-frame® Baseplate — Medtec LLC · Class II
Prone Head Holder — Medtec LLC · Class I
Arthrex TRIMANO quick adapter — Maquet, Inc. · Class I
Uni-frame® Baseplate — Medtec LLC · 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: Qfix

Sources (1)

FDA UDI 8add2468-c707-41e0-871f-a576b50eb72e 35 fields · synced May 30, 2026