Dermalon
Monofilament Nylon,SCE-4,1x Blue Strand
3manufacturers in China registered for this device type
38catalogue 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) | K981582 |
| Record published | 2015-08-30 |
| Record revised | 2025-06-24 (version 10) |
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 |
| Sizes | Length 16 to 40 in |
| Distribution end date | 2020-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 88861756-31 | Length 18 in | In distribution |
| 88861756-41 | Length 18 in | In distribution |
| 88861720-51 | Length 36 in | In distribution |
| 88861756-51 | Length 18 in | In distribution |
| 88861741-11 | Length 18 in | In distribution |
| 88861742-41 | Length 18 in | In distribution |
| SDN-5943G | diameter,3/0,N/A; | In distribution |
| 88861750-41 | Length 30 in | In distribution |
| 88861754-13 | Length 18 in | In distribution |
| 88861727-41 | Length 30 in | In distribution |
| 88861756-21 | Length 18 in | In distribution |
| 88861757-31 | Length 30 in | In distribution |
| 88861742-31 | Length 18 in | In distribution |
| 88861764-51 | Length 30 in | In distribution |
| 88861742-21 | Length 18 in | In distribution |
| 88861744-51 | Length 18 in | In distribution |
| 88861727-51 | Length 30 in | In distribution |
| 88861757-41 | Length 30 in | In distribution |
| 88861747-11 | Length 18 in | In distribution |
| 88861741-21 | Length 18 in | In distribution |
| 88861799-31 | Length 30 in | In distribution |
| 88861741-31 | Length 18 in | In distribution |
| 88861799-51 | Length 30 in | In distribution |
| SDN-5691G | Length 18 in | In distribution |
| 88861744-41 | Length 18 in | In distribution |
| 88861744-31 | Length 18 in | In distribution |
| 88861799-41 | Length 30 in | In distribution |
| 88861749-24 | Length 18 in | In distribution |
| SDN-5696G | diameter,6/0,N/A; | In distribution |
| SDN-5666G | Length 18 in | In distribution |
| 88861756-11 | Length 18 in | In distribution |
| 88861764-41 | Length 30 in | In distribution |
| 88861779-23 | Length 18 in | Withdrawn |
| 88861770-41 | diameter,3/0,N/A; | Withdrawn |
| 88861771-43 | Length 18 in | Withdrawn |
| SDN-5933G | Length 18 in | Withdrawn |
| 88861770-51 | Length 40 in | Withdrawn |
| XX-5013 | Length 16 in | Withdrawn |
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 |
| Monosof | Covidien LP | 256 |
| 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 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2026-06-24 | Class II | Equipment maintenance | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | 135,875 total |
| Covidien | 510(k) number | 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 | 9606 |
| 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 | 87708 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.