Unify PDO Surgical Sutures
UNIFY PDO Surgical Sutures, Absorbable, 4-0, 60mm Straight needle, Rev Cut, 30" Violet.
2manufacturers in China registered for this device type
34catalogue 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 | Applied Dental, Inc. |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| 510(k) | K073614 |
| Record published | 2015-08-19 |
| Record revised | 2021-02-05 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, case of 100, carton of 100, box of 36 |
| Distribution end date | 2022-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-D518R13 | In distribution | |
| XXL-1D30R40 | In distribution | |
| S-D418R13 | In distribution | |
| L-D330R24 | In distribution | |
| M-D318R19 | In distribution | |
| M-D518R19-U | In distribution | |
| S-D618R13 | In distribution | |
| S-D418R13-U | In distribution | |
| M-D430T17 | In distribution | |
| M-D330R19 | In distribution | |
| L-D230XR24 | In distribution | |
| XL-D230T36-U | In distribution | |
| M-D330T17 | In distribution | |
| XL-D030R30 | In distribution | |
| M-D230R19 | In distribution | |
| XXL-D430K60 | In distribution | |
| XL-D230T36 | In distribution | |
| M-D518R19 | In distribution | |
| M-D418R19-U | In distribution | |
| L-D330T26 | In distribution | |
| M-D318R19-U | In distribution | |
| XL-D030T36 | In distribution | |
| L-D330T26-U | In distribution | |
| L-D230T26 | In distribution | |
| L-D230R24 | In distribution | |
| M-D418R19 | In distribution | |
| M-D518R16 | In distribution | |
| M-D418R16 | In distribution | |
| S-D518R13-U | In distribution | |
| M-D430R19 | In distribution | |
| L-D330XR24 | In distribution | |
| XXL-2D30R40 | In distribution | |
| L-D230R24-U | Withdrawn | |
| L-D330R24-U | Withdrawn |
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.