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

SeaDragon2™

Name: SeaDragon2™
Brand: SeaDragon2™

Catalogue number 00884450458068, listed by Merit Medical Systems, Inc., United States, 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 SeaDragon2™
Listed by	Merit Medical Systems, Inc., United States
FDA product code	PTL
Device type	Wire, Guide, Catheter, Exempt
Device class	Class 2
Regulation	21 CFR 870.1330
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2020-08-14
Record revised	2025-05-13 (version 3)

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
Packaging	Pack of 10, pack of 14

Catalogue Numbers

Catalogue numbers for SeaDragon2™
Catalogue number	Size	Status
00884450458068	Guide Wire Compatibility2-0.038″ (0.97 mm)	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
Sunmed guidewire torque device	Sunny Medical Device (Shenzhen) Co., Ltd.	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.