Who else makes this device?

Name: MR Stylet
Brand: MR Stylet

General & Plastic Surgery › SurgicalStylet, Surgical, General & Plastic Surgery

MR Stylet

Catalogue number 4013-06, listed by Clinical Laserthermia Systems AB, Sweden, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

1recall

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GAH
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Shenzhen Xinzhengyu Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	7

Record

Regulatory record for MR Stylet
Listed by	Clinical Laserthermia Systems AB, Sweden
FDA product code	GAH
Device type	Stylet, Surgical, General & Plastic Surgery
Device class	Class 1
Regulation	21 CFR 878.4800
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2016-12-06
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 15 to 25 °C
Packaging	Pack of 10, pack of 5

Catalogue Numbers

Catalogue numbers for MR Stylet
Catalogue number	Size	Status
4013-06		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Lion	Hans Biomed Corp.	17
Wexler Surgical, Inc.	Wexler Surgical, Inc.	9
Orthopediatrics Instrumentation	Orthopediatrics, Corp	7
Summa Orthopaedics System Surgical Instrument	Jeil Medical Corporation	6
Surgical Instrument	Jeil Medical Corporation	6
OrthoPediatrics Cannulated Screw System	Orthopediatrics, Corp	6
Osseoflex®	Merit Medical Systems, Inc.	6
Inlet System Surgical Instrument	Jeil Medical Corporation	5
Disc Preparation Instruments	Highridge Medical, LLC	5
Symmetry Frazier	Aspen Surgical Products, Inc.	5
Visualase	Medtronic Navigation, Inc.	5
Prometheus System Surgical Instrument	Jeil Medical Corporation	5

Showing 12 of 50. All products under Stylet, Surgical, General & Plastic Surgery

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2021-04-01	Class II	Equipment maintenance	single use devices labeled as sterile may not have been adequately sterilized	40 units	2023-08-30

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.