Renovatio
Dual Needle Harpoon PDO Thread Bioabsorbable With Needle-Sterilized Package
2manufacturers in China registered for this device type
28catalogue numbers in this listing
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 | Bonago Medical Solutions LLC |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| 510(k) | K160761 |
| Record published | 2022-11-15 |
| Record revised | 2023-06-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| REN-TWIST-23-90 | 10 | In distribution | |
| REN-ALL4-18-80 | 10 | In distribution | |
| REN-TWIST-27-50 | 10 | In distribution | |
| REN-DUAL-W | 10 | In distribution | |
| REN-TSPRING-29-25 | 10 | In distribution | |
| REN-HARP-21-60 | 10 | In distribution | |
| REN-MESH-19-60 | 10 | In distribution | |
| REN-ALL4-18-100 | 10 | In distribution | |
| REN-HARP-18-100 | 10 | In distribution | |
| REN-RHIN-19-50 | 10 | In distribution | |
| REN-HARP-18-80 | 10 | In distribution | |
| REN-HARP-18-60 | 10 | In distribution | |
| REN-SOFT-21-90 | 10 | In distribution | |
| REN-HARP-18-100-1 | 10 | In distribution | |
| REN-TWIST-26-60 | 10 | In distribution | |
| REN-DUAL-S | 10 | In distribution | |
| REN-T-SPRING-27-38 | 10 | In distribution | |
| REN-HARP-19-60 | 10 | In distribution | |
| REN-T-SPRING-26-60 | 10 | In distribution | |
| REN-SOFT-21-60 | 10 | In distribution | |
| REN-TWIST-29-25 | 10 | In distribution | |
| REN-HARP-19-100 | 10 | In distribution | |
| REN-HARP-21-90 | 10 | In distribution | |
| REN-PUSH-23-38 | 10 | In distribution | |
| REN-RHIN-19-38 | 10 | In distribution | |
| REN-ALL4-18-60 | 10 | In distribution | |
| REN-MESH-19-38 | 10 | In distribution | |
| REN-TWIST-27-38 | 10 | 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 |
| DemeDIOX Barbed | Demetech Corp. | 40 |
| Viola | Meditime Co., Ltd. | 36 |
| Stratafix Spiral | Surgical Specialties México, S. de R.L. de C.V. | 34 |
Showing 12 of 292. All products under Suture, Surgical, Absorbable, Polydioxanone
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.