PDO Max Threads
Molded Levo Max 18gx100mm Sterile Inner
2manufacturers in China registered for this device type
64catalogue 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 | Max Pdo Inc |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| 510(k) | K190245 |
| Record published | 2020-12-12 |
| Record revised | 2021-02-05 (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 | Status |
|---|---|---|
| PM2925R-S | In distribution | |
| PM19100W-SN | In distribution | |
| PM2538S-DC | In distribution | |
| PM1938L-FA | In distribution | |
| PM2360R-S | In distribution | |
| PM2938R-S | In distribution | |
| PM2560S-C | In distribution | |
| PM2360L-FE-BP | In distribution | |
| PM2360L-MT | In distribution | |
| PM18100W-SN | In distribution | |
| PM19100L-SC | In distribution | |
| PM2760S-C | In distribution | |
| PM18100L-SC | In distribution | |
| PM18100W-SN | In distribution | |
| PM2950S-S | In distribution | |
| PM2360L-FE-BP | In distribution | |
| PM2938S-C | In distribution | |
| PM3025S-S | In distribution | |
| PM2690S-C | In distribution | |
| PM18100L-FE-BP | In distribution | |
| PM21100L-FE-BP | In distribution | |
| PM2360L-MT | In distribution | |
| PDO-SC-BL-02 | In distribution | |
| PM3038S-S | In distribution | |
| PM2690S-C | In distribution | |
| PM2338L-MT | In distribution | |
| PM2938R-S | In distribution | |
| PM2950S-S | In distribution | |
| PM1950L-FA | In distribution | |
| PM1860L-FE-BP | In distribution | |
| PM2338L-MT | In distribution | |
| PM2690S-S | In distribution | |
| PM19100W-SN | In distribution | |
| PM3025S-S | In distribution | |
| PM2938S-C | In distribution | |
| PM18100L-FE-BP | In distribution | |
| PM18100L-SE | In distribution | |
| PM2538S-DC | In distribution | |
| PM1860L-FE-BP | In distribution | |
| PM1960L-FE-BP | In distribution | |
| PDO-SC-BL-02 | In distribution | |
| PM2638S-C | In distribution | |
| PM19100L-SC | In distribution | |
| PM2925R-S | In distribution | |
| PM2360R-S | In distribution | |
| PM1950L-FA | In distribution | |
| PM1938L-FA | In distribution | |
| PM3038S-S | In distribution | |
| PM2638S-C | In distribution | |
| PM1960L-FE-BP | In distribution | |
| PM18100L-SC | In distribution | |
| PM21100L-FE-BP | In distribution | |
| PM2690S-S | In distribution | |
| PM3038R-S | In distribution | |
| PM19100L-FE-BP | In distribution | |
| PM19100L-FE-BP | In distribution | |
| PDO-FE-BL-02 | In distribution | |
| PM2760S-C | In distribution | |
| PDO-FE-BL-02 | In distribution | |
| PM2560S-C | In distribution | |
| PM18100L-SE | In distribution | |
| PM2638S-DC | In distribution | |
| PM3038R-S | In distribution | |
| PM2638S-DC | 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 |
| 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 |
| 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.