What is FDA product code PTX?

This product code is the class II exempt counterpart of GAQ, 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 878.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

General & Plastic Surgery › SurgicalSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

Titan™ Double Wire

Name: Titan™ Double Wire
Brand: Titan™ Double Wire

Monofilament 316 LVM Stainless Steel Suture, CCS2 Needle, 59MM, USP 6, 14", 3 PK

Registry build 21.09.26

2manufacturers in China registered for this device type

9catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (1), Tianjin (1).

Chinese manufacturers registered for FDA product code PTX
Manufacturer	City	Province	Registered as	Device types
Dongguan Wanjin Industrial Co., Ltd.	Dongguang	Guangdong	Remanufacturer	41
Jinyuan Medical Equipment(Tianjin)Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	27

Record

Regulatory record for Titan™ Double Wire
Listed by	Jace Medical, LLC, United States
FDA product code	PTX
Device type	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt
Device class	Class 2
Regulation	21 CFR 878.4495
Premarket notification	Exempt
Record published	2021-10-10
Record revised	2025-05-30 (version 5)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Carton of 12, pack of 12
Distribution end date	2022-12-31

Catalogue Numbers

Catalogue numbers for Titan™ Double Wire
Catalogue number	Per pack	Status
132.641.53	3	Withdrawn
132.640.62	2	Withdrawn
132.641.22	2	Withdrawn
132.641.52	2	Withdrawn
132.641.23	3	Withdrawn
132.645.52	2	Withdrawn
132.681.22	2	Withdrawn
132.841.52	2	Withdrawn
132.640.23	3	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Steelex	B Braun Surgical SA	40
ForceFlex	Riverpoint Medical LLC	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.