Net Plug & Patch

PT3H3PS -P is a tridimensional plug with thermoformed tip on a preshaped 6x11 cm base. The product code PT3H3PS-P includes the positioning device in blue PP. PT3H3PS-P is indicated for the…

Registry build 21.09.26

PT3H3PS -P is a tridimensional plug with thermoformed tip on a preshaped 6×11 cm base. The product code PT3H3PS-P includes the positioning device in blue PP. PT3H3PS-P is indicated for the treatment of inguinal hernias, in open repair.

1manufacturer
1catalogue number
1510(k) clearance

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code FTL
Manufacturer City Province Registered as Device types
Shanghai Suokang Medical Implants Co., Ltd. Shang Hai Shanghai Manufacturer 2

Record

Regulatory record for Net Plug & Patch
Listed by Herniamesh SRL, Italy
FDA product code FTL
Device type Mesh, Surgical, Polymeric
Device class Class 2
Regulation 21 CFR 878.3300
Establishment Manufacturer
510(k) K973955
Record published 2021-10-13
Record revised 2025-08-18 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Net Plug & Patch
Catalogue number Size Status
PT3H3PS-P In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Technical Products Technical Products, Inc. 143
Parietex Sofradim Production 82
DynaMesh FEG Textiltechnik Forschungs- und Entwicklungsges. mbH 45
Symbotex Sofradim Production 35
Silicone Sheeting Reinforced Bentec Medical OpCo, LLC. 33
Parietene Sofradim Production 32
C-QUR Atrium Medical Corporation 31
ProGrip Sofradim Production 31
Silicone Sheeting Non-Reinforced Bentec Medical OpCo, LLC. 31
Prolite Atrium Medical Corporation 31
Gore Seamguard Bioabsorbable Staple Line Reinforce W. L. Gore & Associates, Inc. 30
Surgimesh®wn Aspide Medical 28

Showing 12 of 148. All products under Mesh, Surgical, Polymeric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K973955 1998-05-11

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number Decision Trade name Approved to
P990028 2003-12-04 FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT Genzyme Corporation

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer