What is FDA product code PTL?

This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Cardiovascular › DiagnosticWire, Guide, Catheter, Exempt

Sunmed Guidewire Torque Device

Name: Sunmed guidewire torque device
Brand: Sunmed guidewire torque device

Catalogue number plastic type, white, listed by Sunny Medical Device (Shenzhen) Co., Ltd., China, under Wire, Guide, Catheter, Exempt. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Beijing (2), Guangdong (1), Shanghai (1).

Chinese manufacturers registered for FDA product code PTL
Manufacturer	City	Province	Registered as	Device types
Sunny Medical Device (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	11
Shanghai INT Medical Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	10
Lepu Medical Technology (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7
Terumo Medical Products (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	7
Beijing Target Medical Technologies Inc.	Beijing	Beijing	Contract manufacturer	7

Record

Regulatory record for Sunmed guidewire torque device
Listed by	Sunny Medical Device (Shenzhen) Co., Ltd., China
FDA product code	PTL
Device type	Wire, Guide, Catheter, Exempt
Device class	Class 2
Regulation	21 CFR 870.1330
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2022-01-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Sunmed guidewire torque device
Catalogue number	Size	Status
plastic type, white		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Angioway	Lepu Medical Technology (Beijing) Co., Ltd.	6
Speed Torque	Vascugenix, LLC	6
H2O Torq™	Merit Medical Systems, Inc.	2
Pin Vise	Merit Medical Systems, Inc.	2
SeaDragon2™	Merit Medical Systems, Inc.	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.