Stratafix Spiral
2SH -0- PDO 14 X 14 13MM Leader
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 | Surgical Specialties México, S. de R.L. de C.V. |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Record published | 2015-10-22 |
| Record revised | 2023-12-25 (version 8) |
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 |
| Packaging | Box of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SXPD2B408 | 0 USP | In distribution |
| SXPD2B422 | 3-0 USP | In distribution |
| SXPD2B410 | 1 USP | In distribution |
| SXPD2B418 | 0 USP | In distribution |
| SXPD2B415 | 1 USP | In distribution |
| SXPD1B400 | 0 USP | In distribution |
| SXPD2B419 | 2-0 USP | In distribution |
| SXPD2B413 | 0 USP | In distribution |
| SXPD2B425 | 3-0 USP | In distribution |
| SXPD2B411 | 1 USP | In distribution |
| SXPD2B407 | 0 USP | In distribution |
| SXPD2B402 | 2 USP | In distribution |
| SXPD2B403 | 2 USP | In distribution |
| SXPD1B401 | 0 USP | In distribution |
| SXPD2B201 | 2 USP | In distribution |
| SXPD2B406 | 0 USP | In distribution |
| SXPD2B412 | 0 USP | In distribution |
| SXPD1B100 | 2-0 USP | In distribution |
| SXPD2B414 | 0 USP | In distribution |
| SXPD2B405 | 2 USP | In distribution |
| SXPD1B101 | 3-0 USP | In distribution |
| SXPD2B426 | 3-0 USP | In distribution |
| SXPD2B416 | 2 USP | In distribution |
| SXPD2B417 | 2-0 USP | In distribution |
| SXPD2B404 | 1 USP | In distribution |
| SXPD2B421 | 4-0 USP | In distribution |
| SXPD2B423 | 3-0 USP | In distribution |
| SXPD2B401 | 2 USP | In distribution |
| SXPD2B202 | 2 USP | In distribution |
| SXPD2B200 | 2 USP | In distribution |
| SXPD2B409 | 1 USP | In distribution |
| SXPD2B400 | 2 USP | In distribution |
| SXPD2B424 | 3-0 USP | In distribution |
| SXPD2B420 | 0 USP | 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 |
| Unify PDO Surgical Sutures | Applied Dental, Inc. | 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.