Monosof
Monofilament Nylon, C-14 Cutting, 1x Black Strand
3manufacturers in China registered for this device type
256catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| 510(k) | K900531 |
| Record published | 2015-09-01 |
| Record revised | 2025-06-24 (version 15) |
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 |
| Storage | Handling environment temperature up to 130 °F |
| Packaging | Case of 36, case of 12, case of 24, pack_or_inner_pack of 12 |
| Sizes | Length 3 to 120 in |
| Distribution end date | 2026-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CN-793 | Length 40 in | In distribution |
| SN-5660G | Length 18 in | In distribution |
| N-2716K | Length 12 in | In distribution |
| SN-871 | Length 18 in | In distribution |
| N-2548 | Length 5 in | In distribution |
| N-2543 | Length 5 in | In distribution |
| SN-643 | Length 30 in | In distribution |
| SN-1954 | Length 18 in | In distribution |
| SN-781 | Length 36 in | In distribution |
| SN-761 | diameter,5/0,N/A; | In distribution |
| N-2756K | Length 12 in | In distribution |
| SN-5690 | Length 18 in | In distribution |
| N-2547 | Length 5 in | In distribution |
| SN-615 | Length 36 in | In distribution |
| SN-5668 | Length 18 in | In distribution |
| SN-673G | Length 30 in | In distribution |
| SN-771G | diameter,5/0,N/A; | In distribution |
| SN-5666G | Length 18 in | In distribution |
| CN-925 | Length 40 in | In distribution |
| SN-659G | diameter,5/0,N/A; | In distribution |
| SN-617 | Length 36 in | In distribution |
| SN-5662 | Length 18 in | In distribution |
| SN-5696G | diameter,6/0,N/A; | In distribution |
| SN-661G | Length 18 in | In distribution |
| SN-658 | diameter,4/0,N/A; | In distribution |
| CN-823-L | diameter,0,N/A; | In distribution |
| SN-1966 | Length 18 in | In distribution |
| GN-284 | Length 36 in | In distribution |
| SN-5699 | Length 18 in | In distribution |
| SN-5699G | Length 18 in | In distribution |
| SN-763 | diameter,3/0,N/A; | In distribution |
| SN-663 | diameter,3/0,N/A; | In distribution |
| SN-672 | Length 30 in | In distribution |
| CN-723 | diameter,0,N/A; | In distribution |
| SN-1693 | Length 18 in | In distribution |
| SN-747 | Length 36 in | In distribution |
| SN-664G | Length 30 in | In distribution |
| SN-1647 | diameter,7/0,N/A; | In distribution |
| SN-681 | Length 30 in | In distribution |
| SN-5694 | Length 18 in | In distribution |
| SN-765 | Length 30 in | In distribution |
| SN-368 | Length 30 in | In distribution |
| N-2760K | Length 12 in | In distribution |
| SN-5691 | Length 18 in | In distribution |
| CN-822 | Length 36 in | In distribution |
| N-2719K | Length 12 in | In distribution |
| N-2966K | Length 12 in | In distribution |
| SN-5696 | Length 18 in | In distribution |
| SN-666 | Length 36 in | In distribution |
| N-2799-K | Length 12 in | In distribution |
| SN-667G | Length 18 in | In distribution |
| N-1603G | Length 3 in | In distribution |
| SN-5663G | Length 18 in | In distribution |
| SN-5668G | Length 18 in | In distribution |
| N-59 | diameter,2/0,N/A; | In distribution |
| SN-5767G | diameter,6/0,N/A; | In distribution |
| SN-5663 | Length 18 in | In distribution |
| N-2717-K | Length 12 in | In distribution |
| N-63 | Length 18 in | In distribution |
| SN-661 | Length 18 in | In distribution |
| SN-627 | Length 30 in | In distribution |
| SN-673 | Length 30 in | In distribution |
| SN-662 | Length 18 in | In distribution |
| SN-771 | Length 36 in | In distribution |
| SN-1994 | Length 18 in | In distribution |
| SN-629 | Length 30 in | In distribution |
| SN-5698G | Length 18 in | In distribution |
| SN-788 | Length 36 in | In distribution |
| SN-5662G | Length 18 in | In distribution |
| N-2541 | Length 5 in | In distribution |
| CN-825-L | Length 60 in | In distribution |
| SN-5669 | Length 18 in | In distribution |
| N-2781K | Length 18 in | In distribution |
| N-2718K | diameter,10/0,N/A; | In distribution |
| SN-649 | Length 36 in | In distribution |
| SN-1689G | diameter,6/0,N/A; | In distribution |
| N-2714K | diameter,8/0,N/A; | In distribution |
| SN-758 | Length 18 in | In distribution |
| SN-247 | diameter,3/0,N/A; | In distribution |
| SN-5697 | Length 18 in | In distribution |
| SN-626 | Length 30 in | In distribution |
| SN-689 | Length 30 in | In distribution |
| N-2786K | Length 12 in | In distribution |
| SN-671G | Length 30 in | In distribution |
| SN-766 | Length 30 in | In distribution |
| N-2533 | Length 5 in | In distribution |
| SN-772G | Length 10 in | In distribution |
| SN-682 | diameter,2/0,N/A; | In distribution |
| CN-926 | diameter,1,N/A; | In distribution |
| N-2787K | Length 12 in | In distribution |
| SN-782 | Length 36 in | In distribution |
| N-2514 | Length 5 in | In distribution |
| SN-630 | Length 30 in | In distribution |
| SN-641 | Length 30 in | In distribution |
| N-2531 | Length 5 in | In distribution |
| SN-5666 | Length 18 in | In distribution |
| CN-824 | Length 60 in | In distribution |
| N-2532 | Length 5 in | In distribution |
| SN-660 | diameter,6/0,N/A; | In distribution |
| SN-1647G | Length 18 in | In distribution |
| SN-628 | Length 30 in | In distribution |
| SN-631 | Length 30 in | In distribution |
| SN-648 | Length 36 in | In distribution |
| SN-5694G | diameter,4/0,N/A; | In distribution |
| CN-623 | Length 40 in | In distribution |
| SN-5661G | diameter,5/0,N/A; | In distribution |
| SN-5862G | Length 18 in | In distribution |
| SN-663G | Length 18 in | In distribution |
| SN-5698 | Length 18 in | In distribution |
| SN-664 | Length 30 in | In distribution |
| N-2757K | Length 6 in | In distribution |
| SN-1956 | diameter,6/0,N/A; | In distribution |
| X-1168 | diameter,2,N/A; | In distribution |
| CN-791 | diameter,2/0,N/A; | In distribution |
| N-2540 | diameter,10/0,N/A; | In distribution |
| SN-5677 | Length 18 in | In distribution |
| SN-764G | Length 18 in | In distribution |
| N-2736K | diameter,10/0,N/A; | In distribution |
| SN-5667G | Length 18 in | In distribution |
| CN-825 | diameter,2,N/A; | In distribution |
| N-2704K | Length 12 in | In distribution |
| N-2734K | Length 8 in | In distribution |
| SN-616 | Length 36 in | In distribution |
| SN-674 | Length 30 in | In distribution |
| N-2771-K | Length 12 in | In distribution |
| SN-1995 | Length 18 in | In distribution |
| XX-5204J | Length 18 in | In distribution |
| N-64 | Length 18 in | In distribution |
| SN-1955 | Length 18 in | In distribution |
| N-2530 | Length 5 in | In distribution |
| SN-5669G | Length 18 in | In distribution |
| SN776G | Diameter, 1, N/A; | In distribution |
| CN723G | Diameter, 0, N/A; | In distribution |
| N-2766K | Length 6 in | In distribution |
| SN-665 | Length 36 in | In distribution |
| SN-669 | diameter,3/0,N/A; | In distribution |
| N-2770-K | diameter,10/0,N/A; | In distribution |
| GN-283 | diameter,2/0,N/A; | In distribution |
| SN-777 | diameter,2,N/A; | In distribution |
| SN-5667 | Length 18 in | In distribution |
| SN-881 | diameter,3/0,N/A; | In distribution |
| N-2730-K | Length 8 in | In distribution |
| SN-659 | Length 18 in | In distribution |
| SN-775 | Length 36 in | In distribution |
| SN-367 | Length 30 in | In distribution |
| SN-694 | diameter,2/0,N/A; | In distribution |
| SN-5690G | Length 18 in | In distribution |
| SN-644 | Length 36 in | In distribution |
| CN-722 | diameter,1,N/A; | In distribution |
| SN-662G | diameter,4/0,N/A; | In distribution |
| N-2546 | diameter,9/0,N/A; | In distribution |
| SN-5665G | Length 18 in | In distribution |
| SN-693 | Length 36 in | In distribution |
| N-2761K | Length 18 in | In distribution |
| CN793G | Diameter, 1, N/A; | In distribution |
| X-1317 | Length 30 in | In distribution |
| CN-771 | Length 40 in | In distribution |
| SN-3965 | Length 18 in | In distribution |
| N-2500 | Length 5 in | In distribution |
| SN-3697 | Length 18 in | In distribution |
| CN-830-L | Length 60 in | In distribution |
| SN-5670 | Length 18 in | In distribution |
| CN-225 | diameter,0,N/A; | In distribution |
| SN-552G | diameter,4/0,N/A; | In distribution |
| SN-776 | Length 36 in | In distribution |
| SN-760 | Length 30 in | In distribution |
| N-2721-K | Length 8 in | In distribution |
| SN-764 | diameter,2/0,N/A; | In distribution |
| N-2510 | diameter,11/0,N/A; | In distribution |
| SN-671 | Length 30 in | In distribution |
| SN-728 | Length 40 in | In distribution |
| N-2705K | Length 12 in | In distribution |
| SN-670 | Length 30 in | In distribution |
| SN-653 | Length 18 in | In distribution |
| CN-490 | Length 30 in | In distribution |
| N-2513 | diameter,10/0,N/A; | In distribution |
| N-2512 | Length 5 in | In distribution |
| GNJ-283 | diameter,2/0,N/A; | In distribution |
| SN-762 | diameter,4/0,N/A; | In distribution |
| CN-792 | Length 40 in | In distribution |
| SN-688 | diameter,2/0,N/A; | In distribution |
| SN-667 | Length 18 in | In distribution |
| SN-1689 | diameter,6/0,N/A; | In distribution |
| SN-3695 | diameter,5/0,N/A; | In distribution |
| N-2544 | Length 5 in | In distribution |
| SN-1964 | diameter,4/0,N/A; | In distribution |
| CN-819 | Length 30 in | In distribution |
| SN-872 | diameter,4/0,N/A; | In distribution |
| SN-750 | diameter,2/0,N/A; | In distribution |
| SN-3686 | Length 18 in | In distribution |
| SN-790 | Length 36 in | In distribution |
| SN-770G | Length 10 in | In distribution |
| N-2967 | Length 12 in | In distribution |
| SN-568 | Length 18 in | In distribution |
| CN-724 | Length 40 in | In distribution |
| N-60 | Length 18 in | Withdrawn |
| SN648G | diameter,3/0,N/A; | Withdrawn |
| X-1126L | Length 120 in | Withdrawn |
| X-1212 | Length 60 in | Withdrawn |
| SN-569 | Length 18 in | Withdrawn |
| X-1021L | Length 80 in | Withdrawn |
| X-1229 | Length 20 in | Withdrawn |
| X-1284 | diameter,4/0,N/A; | Withdrawn |
| SN-619 | Length 36 in | Withdrawn |
| SN5699GMDL | Diameter, 4/0, N/A; | Withdrawn |
| SN3697GMDL | Length 18 in | Withdrawn |
| SN5668GMDL | Diameter, 5/0, N/A; | Withdrawn |
| SN-1683 | Length 30 in | Withdrawn |
| CN-824-L | Length 60 in | Withdrawn |
| X-1285 | Length 30 in | Withdrawn |
| SN5862GMDL | Diameter, 4/0, N/A; | Withdrawn |
| CN-500 | diameter,1,N/A; | Withdrawn |
| SN-3962 | Length 18 in | Withdrawn |
| SN5669GMDL | Diameter, 3/0, N/A; | Withdrawn |
| CN-290 | Length 18 in | Withdrawn |
| SN-242GK | Length 18 in | Withdrawn |
| XX-5198 | Length 30 in | Withdrawn |
| SN661GMDL | Diameter, 5/0, N/A; | Withdrawn |
| SN-1684 | Length 30 in | Withdrawn |
| SN-641G | Length 30 in | Withdrawn |
| SN-660G | Length 18 in | Withdrawn |
| SN-5691G | Length 18 in | Withdrawn |
| SN3695GMDL | Diameter, 5/0, N/A; | Withdrawn |
| SN-867 | Length 30 in | Withdrawn |
| N-2810 | Length 5 in | Withdrawn |
| SN-1792 | Length 30 in | Withdrawn |
| SN764GMDL | Length 18 in | Withdrawn |
| X-1316 | Length 30 in | Withdrawn |
| SN-882 | Length 36 in | Withdrawn |
| SN5662GMDL | Length 18 in | Withdrawn |
| X-1211 | Length 60 in | Withdrawn |
| SN-618 | Length 36 in | Withdrawn |
| SN-1854 | diameter,4/0,N/A; | Withdrawn |
| SN5696GMDL | Length 18 in | Withdrawn |
| SN-3500 | Length 18 in | Withdrawn |
| CN-845 | diameter,2,N/A; | Withdrawn |
| XX-5150 | Length 18 in | Withdrawn |
| SN-1682 | Length 30 in | Withdrawn |
| XX-5197 | Length 30 in | Withdrawn |
| SN5667GMDL | Diameter, 4/0, N/A; | Withdrawn |
| SN-5658G | Length 30 in | Withdrawn |
| SN5666GMDL | Diameter, 5/0, N/A; | Withdrawn |
| XX-5203J | Length 18 in | Withdrawn |
| SN5663GMDL | Diameter, 3/0, N/A; | Withdrawn |
| X-1349L | diameter,0,N/A; | Withdrawn |
| SN663GMDL | Length 18 in | Withdrawn |
| CN830GL | Length 60 in | Withdrawn |
| N-2740-K | Length 6 in | Withdrawn |
| SN-1954G | Length 18 in | Withdrawn |
| CN-624 | diameter,1,N/A; | Withdrawn |
Showing 250 of 256 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| Dafilon | B Braun Surgical SA | 592 |
| WEGO-Nylon Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 279 |
| Ethilon | Ethicon, Inc. | 272 |
| DemeLON Multi | Demetech Corp. | 227 |
| Surgilon | Covidien LP | 135 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 127 |
| Supramid Extra | S. Jackson, Inc. | 119 |
| Mani Sutures Nylon | Mani, Inc. | 88 |
| Onatec | Surgical Specialties México, S. de R.L. de C.V. | 75 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 73 |
| Trelon | B Braun Surgical SA | 72 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2023-12-21 | Class II | Process control | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood | 46,812 US; 68,976 OUS |
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 12732 units |
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 54288 units |
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 |
|---|---|---|---|
| N85060 | 1988-02-22 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. |
| N85316 | 1986-06-20 | ETHILON/NUROLON NYLON SUTURES | Ethicon, Inc. |
| N80838 | 1985-07-23 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. |
| N83511 | 1982-05-18 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, 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.