Monoplus
Monoplus Violet 1 (4)150CM HRT43S(M)LOOP
2manufacturers in China registered for this device type
697catalogue 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 | B Braun Surgical SA |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Record published | 2015-08-11 |
| Record revised | 2026-03-27 (version 23) |
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 | Carton of 30 |
| Sizes | Length 45 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C0024143 | Length 90.00 cm | 36 | Withdrawn |
| C0024571 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024448 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C0024175 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X0024104 | Length 90.00 cm | 4 | Withdrawn |
| C0024186 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0024965 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X0024347 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024342 | Length 150.00 cm | 4 | Withdrawn |
| G0024186 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| X0024812 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024538 | Length 90.00 cm | 36 | Withdrawn |
| X0024525 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024109 | Length 45.00 cm | 4 | Withdrawn |
| X0024467 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| C0024028 | Length 120.00 cm | 36 | Withdrawn |
| C0024002 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024081 | Length 45.00 cm | 4 | Withdrawn |
| X0024568 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024598 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024146 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024168 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0024514 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0024171 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024532 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| M0024962 | Thread Material : polydioxanone | 6 | Withdrawn |
| X0024774 | Length 45.00 cm | 4 | Withdrawn |
| X0024122 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024991 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024003 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| X0024602 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| X0024045 | Length 70.00 cm | 4 | Withdrawn |
| C0024282 | Length 70.00 cm | 36 | Withdrawn |
| C0024102 | Thread Material : polydioxanone | 36 | Withdrawn |
| M0024684 | Size of Thread (USP – Others) : 3/0 | 6 | Withdrawn |
| X0024085 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024401 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X0024188 | Length 70.00 cm | 4 | Withdrawn |
| B0024153 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| G0024025 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0024068 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| B0024079 | Thread Material : polydioxanone | 24 | Withdrawn |
| C0024515 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024133 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024115 | Thread Material : polydioxanone | 12 | Withdrawn |
| X0024814 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024305 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024467 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| B0024416 | Size of Thread (USP – Others) : 0 | 24 | Withdrawn |
| C0024253 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024896 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024823 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0024568 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| X0024824 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| C0024105 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0024087 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024194 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X0024836 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024843 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024002 | Length 70.00 cm | 12 | Withdrawn |
| X0024634 | Length 70.00 cm | 4 | Withdrawn |
| C0024981 | Length 45.00 cm | 36 | Withdrawn |
| C0024764 | Length 45.00 cm | 36 | Withdrawn |
| B0024393 | Length 150.00 cm | 24 | Withdrawn |
| C0024639 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024847 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X0024186 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024194 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| X0024057 | Thread Material : polydioxanone | 4 | Withdrawn |
| M0024950 | Thread Material : polydioxanone | 6 | Withdrawn |
| X0024541 | Length 70.00 cm | 4 | Withdrawn |
| X0024802 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024098 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C0024560 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024626 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| B0024925 | Thread Material : polydioxanone | 24 | Withdrawn |
| C0024110 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| X0024086 | Length 70.00 cm | 4 | Withdrawn |
| C0024937 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X0024343 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024644 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0024046 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0024108 | Length 70.00 cm | 36 | Withdrawn |
| C0024548 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024189 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024261 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G0024394 | Thread Material : polydioxanone | 12 | Withdrawn |
| C0024916 | Length 45.00 cm | 36 | Withdrawn |
| X0024524 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024714 | Length 45.00 cm | 36 | Withdrawn |
| C0024014 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0024928 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024027 | Length 70.00 cm | 36 | Withdrawn |
| X0024990 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024026 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024078 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024825 | Length 70.00 cm | 36 | Withdrawn |
| G0024916 | Thread Material : polydioxanone | 12 | Withdrawn |
| X0024294 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024535 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X0024134 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| C0024145 | Thread Material : polydioxanone | 36 | Withdrawn |
| B0024878 | Length 150.00 cm | 24 | Withdrawn |
| C0024564 | Length 150.00 cm | 36 | Withdrawn |
| C0024523 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024433 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024802 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G0024168 | Thread Material : polydioxanone | 12 | Withdrawn |
| X0024206 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024088 | Length 70.00 cm | 4 | Withdrawn |
| C0024164 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X0024603 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| G0024458 | Thread Material : polydioxanone | 12 | Withdrawn |
| C0024179 | Length 70.00 cm | 36 | Withdrawn |
| X0024128 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C0024926 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0024185 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| G0024133 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| G0024114 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| B0024357 | Length 150.00 cm | 24 | Withdrawn |
| G0024078 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C0024311 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024567 | Length 150.00 cm | 12 | Withdrawn |
| X0024232 | Length 70.00 cm | 4 | Withdrawn |
| C0024630 | Length 90.00 cm | 36 | Withdrawn |
| X0024036 | Thread Material : polydioxanone | 4 | Withdrawn |
| G0024118 | Length 90.00 cm | 12 | Withdrawn |
| C0024119 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| C0024605 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024188 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024034 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| G0024027 | Thread Material : polydioxanone | 12 | Withdrawn |
| C0024088 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G0024102 | Thread Material : polydioxanone | 12 | Withdrawn |
| X0024605 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C0024063 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024393 | Thread Material : polydioxanone | 12 | Withdrawn |
| X0024353 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024067 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G0024306 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0024019 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0024098 | Length 150.00 cm | 24 | Withdrawn |
| C0024062 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024833 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024037 | Length 70.00 cm | 36 | Withdrawn |
| X0024567 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| C0024056 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0024424 | Length 90.00 cm | 36 | Withdrawn |
| G0024284 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C0024434 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X0024724 | Length 70.00 cm | 4 | Withdrawn |
| X0024722 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024634 | Length 70.00 cm | 36 | Withdrawn |
| C0024036 | Length 70.00 cm | 36 | Withdrawn |
| X0024185 | Thread Material : polydioxanone | 4 | Withdrawn |
| G0024722 | Length 70.00 cm | 12 | Withdrawn |
| G0024634 | Length 70.00 cm | 12 | Withdrawn |
| C0024814 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024103 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024984 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0024721 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| B0024726 | Length 70.00 cm | 24 | Withdrawn |
| C0024435 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X0024394 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| M0024796 | Thread Material : polydioxanone | 6 | Withdrawn |
| C0024439 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024519 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024466 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0024994 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024453 | Thread Material : polydioxanone | 12 | Withdrawn |
| C0024045 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024034 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C0024528 | Thread Material : polydioxanone | 36 | Withdrawn |
| B0024089 | Thread Material : polydioxanone | 24 | Withdrawn |
| C0024625 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024012 | Length 70.00 cm | 36 | Withdrawn |
| C0024031 | Length 120.00 cm | 36 | Withdrawn |
| X0024517 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| C0024711 | Length 90.00 cm | 36 | Withdrawn |
| X0024624 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| C0024836 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024407 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024222 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024613 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| B0024267 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0024090 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| B0024347 | Thread Material : polydioxanone | 24 | Withdrawn |
| C0024316 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0024028 | Thread Material : polydioxanone | 12 | Withdrawn |
| C0024136 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024635 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| G0024358 | Thread Material : polydioxanone | 12 | Withdrawn |
| X0024094 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| C0024238 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024907 | Thread Material : polydioxanone | 4 | Withdrawn |
| B0024096 | Thread Material : polydioxanone | 24 | Withdrawn |
| G0024106 | Thread Material : polydioxanone | 12 | Withdrawn |
| C0024111 | Length 70.00 cm | 36 | Withdrawn |
| C0024976 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0024543 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0024224 | Length 70.00 cm | 36 | Withdrawn |
| C0024352 | Length 90.00 cm | 36 | Withdrawn |
| X0024283 | Length 70.00 cm | 4 | Withdrawn |
| X0024458 | Length 90.00 cm | 4 | Withdrawn |
| X0024133 | Thread Material : polydioxanone | 4 | Withdrawn |
| G0024294 | Length 70.00 cm | 12 | Withdrawn |
| C0024112 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0024436 | Thread Material : polydioxanone | 12 | Withdrawn |
| X0024801 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024004 | Length 70.00 cm | 36 | Withdrawn |
| C0024812 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024610 | Length 70.00 cm | 36 | Withdrawn |
| X0024332 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024131 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024625 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0024239 | Length 90.00 cm | 36 | Withdrawn |
| G0024813 | Thread Material : polydioxanone | 12 | Withdrawn |
| C0024620 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024589 | Length 70.00 cm | 36 | Withdrawn |
| X0024393 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024055 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| X0024157 | Thread Material : polydioxanone | 4 | Withdrawn |
| G0024520 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0024614 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0024861 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024066 | Thread Material : polydioxanone | 36 | Withdrawn |
| X0024027 | Length 70.00 cm | 4 | Withdrawn |
| C0024101 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024516 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024121 | Length 90.00 cm | 36 | Withdrawn |
| C0024725 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024985 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0024858 | Thread Material : polydioxanone | 24 | Withdrawn |
| C0024824 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0024982 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024877 | Thread Material : polydioxanone | 36 | Withdrawn |
| C0024025 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0024005 | Length 70.00 cm | 36 | Withdrawn |
| X0024813 | Thread Material : polydioxanone | 4 | Withdrawn |
| X0024135 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024353 | Length 90.00 cm | 36 | Withdrawn |
| M0024876 | Length 45.0 cm | 6 | Withdrawn |
| X0024243 | Thread Material : polydioxanone | 4 | Withdrawn |
| C0024519 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024897 | Length 70.00 cm | 12 | Withdrawn |
| C0024521 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0024447 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0024603 | Thread Material : polydioxanone | 36 | Withdrawn |
| G0024004 | Thread Material : polydioxanone | 12 | Withdrawn |
| G0024022 | Thread Material : polydioxanone | 12 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeDIOX | Demetech Corp. | 994 |
| 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 |
| 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.