What is FDA product code QLV?

An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.

Neurology › SurgicalField Generator Positioning Device

Thompson

Name: Thompson
Brand: Thompson

Stealth AXiS™ Bed Rail Clamp Adapter

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code QLV
Manufacturer	City	Province	Registered as	Device types
Weihai Dishang Medical Technology Co., Ltd.	Weihai	Shandong	Contract manufacturer	16

Record

Regulatory record for Thompson
Listed by	Thompson Surgical Instruments, Inc., United States
FDA product code	QLV
Device type	Field Generator Positioning Device
Device class	Class 1
Regulation	21 CFR 882.4565
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2025-05-16
Record revised	2026-05-01 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Thompson
Catalogue number	Size	Status
9736514		In distribution
9736515		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
TGS	Stryker GmbH	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.