DemeDIOX Barbed
DemeDIOX Barbed is an absorbable monofilament suture made from polydioxanone. Spiral, one-directional barbs engage tissue so that a soft tissue closure can be retained without tying…
DemeDIOX Barbed is an absorbable monofilament suture made from polydioxanone. Spiral, one-directional barbs engage tissue so that a soft tissue closure can be retained without tying surgical knots.
The suture is violet, using D&C Violet No. 2 dye. It is available with or without attached needles in sizes from 5-0 through 2.
Listed Item
Absorbable Polidioxanone Barbed Surgical Suture
Suture Configuration
The barbs are formed along the strand rather than supplied as separate anchors. The material is intended for soft tissue approximation where absorbable sutures are appropriate. Devices are supplied sterile after ethylene oxide processing and intended for single use. Their barbed diameter differs from conventional smooth-suture dimensional requirements.
Who Else Makes It
Concentrated in Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Demetech Corp., United States |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K191361 |
| Record published | 2026-04-20 |
| Record revised | 2026-04-23 (version 2) |
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 |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PXB180126B0U1 | In distribution | |
| PXB883026B0U1 | In distribution | |
| PXB882037B0U1 | In distribution | |
| PXB5382036B0U1 | In distribution | |
| PXB5880148C0B | In distribution | |
| PXB5380026B1U1 | In distribution | |
| PXB882026B0U1 | In distribution | |
| PXB2980026B1U1 | In distribution | |
| PXB180148B0U1 | In distribution | |
| PXB5782026G13B | In distribution | |
| PXB680236C0B | In distribution | |
| PXB280148C0B | In distribution | |
| PXB5383022B0U1 | In distribution | |
| PXB2982036B0U1 | In distribution | |
| PXB880037B0U1 | In distribution | |
| PXB1180136B0U1 | In distribution | |
| PXB680037B0U1 | In distribution | |
| PXB5380036B0U1 | In distribution | |
| PXB880036B0U1 | In distribution | |
| PXB2982026B1U1 | In distribution | |
| PXB1482026B0U1 | In distribution | |
| PXB1183026B0U1 | In distribution | |
| PXB1182026B0U1 | In distribution | |
| PXB5480036C0B | In distribution | |
| PXB180140B0U1 | In distribution | |
| PXB1482027H0U1 | In distribution | |
| PXB5482019G13B | In distribution | |
| PXB1182036C0B | In distribution | |
| PXB1482036B0U1 | In distribution | |
| PXB883017B0U1 | In distribution | |
| PXB180136B0U1 | In distribution | |
| PXB5383026B0U1 | In distribution | |
| PXB5382026B0U1 | In distribution | |
| PXB2982026B0U1 | In distribution | |
| PXB1480036B0U1 | In distribution | |
| PXB2983026B0U1 | In distribution | |
| PXB5880036C0B | In distribution | |
| PXB2983017B0U1 | In distribution | |
| PXB280148B0U1 | In distribution | |
| PXB1483026B0U1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeDIOX | Demetech Corp. | 994 |
| Monoplus | B Braun Surgical SA | 697 |
| PDS | Ethicon, Inc. | 430 |
| Wego-PDO Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 180 |
| Stratafix | Ethicon, Inc. | 172 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 74 |
| PDO Max Threads | Max Pdo Inc | 64 |
| Assufil Monofilamento | Assut Europe | 50 |
| LES Encres | Meditime Co., Ltd. | 42 |
| Viola | Meditime Co., Ltd. | 36 |
| Stratafix Spiral | Surgical Specialties México, S. de R.L. de C.V. | 34 |
| Unify PDO Surgical Sutures | Applied Dental, Inc. | 34 |
Showing 12 of 292. All products under Suture, Surgical, Absorbable, Polydioxanone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191361 | 2019-11-07 |
| K181582 | 2018-08-27 |
| K082097 | 2010-01-08 |
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.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N18331 | 1986-06-06 | PDS SUTURE (DYED) | Ethicon, Inc. |
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.