Trelon
Trelon Black 0 (3,5) 8X45CM HR22SS TO TS
3manufacturers in China registered for this device type
72catalogue 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 | B Braun Surgical SA |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Record published | 2015-08-26 |
| Record revised | 2026-04-13 (version 14) |
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 |
| Sizes | Length 45 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M0790085 | Size of Thread (USP – Others) : 4/0 | 6 | Withdrawn |
| C0780070 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| B0790315 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0790225 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| C0790095 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| M0790206 | Size of Thread (USP – Others) : 2/0 | 6 | Withdrawn |
| M0790135 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| B0790319 | Length 100.0 cm | 24 | Withdrawn |
| B0780084 | Length 45.00 cm | 24 | Withdrawn |
| C0790295 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| C0790319 | Length 100.00 cm | 36 | Withdrawn |
| C0780082 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0780069 | Length 45.00 cm | 36 | Withdrawn |
| C0780054 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0790425 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| B0780007 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0780068 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| M0790235 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| C0780056 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0780067 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| C0780108 | Length 100.00 cm | 36 | Withdrawn |
| C0790415 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0780101 | Thread Material : polyamide 6/6 | 12 | Withdrawn |
| C0790385 | Length 45.00 cm | 36 | Withdrawn |
| M0790216 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| B0780018 | Length 75.00 cm | 24 | Withdrawn |
| C0790006 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| C0780081 | Length 45.00 cm | 36 | Withdrawn |
| C0780080 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| C0780025 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| G0780102 | Length 250.00 cm | 12 | Withdrawn |
| M0790245 | Length 45.00 cm | 6 | Withdrawn |
| C0780057 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| G0780099 | Thread Material : polyamide 6/6 | 12 | Withdrawn |
| C0780065 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| B0790495 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| M0790185 | Length 45.00 cm | 6 | Withdrawn |
| C0790056 | Length 75.00 cm | 36 | Withdrawn |
| M0790305 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| C0790296 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| M0790205 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| C0790345 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0790046 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| C0780024 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| M0790236 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| C0780055 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| M0790395 | Size of Thread (USP – Others) : 1 | 6 | Withdrawn |
| C0780016 | Length 75.00 cm | 36 | Withdrawn |
| C0780015 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0780053 | Length 75.00 cm | 36 | Withdrawn |
| C0780110 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| M0790446 | Size of Thread (USP – Others) : 0 | 6 | Withdrawn |
| C0790065 | Length 45.00 cm | 36 | Withdrawn |
| C0790315 | Thread Material : polyamide 6/6 | 36 | Withdrawn |
| B0780008 | Thread Material : polyamide 6/6 | 24 | Withdrawn |
| M0790275 | Length 45.00 cm | 6 | Withdrawn |
| M0790285 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| M0790176 | Size of Thread (USP – Others) : 3/0 | 6 | Withdrawn |
| B0780083 | Length 45.00 cm | 24 | Withdrawn |
| M0790145 | Thread Material : polyamide 6/6 | 6 | Withdrawn |
| M0790215 | Length 75.00 cm | 6 | Withdrawn |
| C0780066 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| M0790559 | Size of Thread (USP – Others) : 2/0 | 6 | Withdrawn |
| B0780002 | Length 45.00 cm | 24 | Withdrawn |
| G0780100 | Thread Material : polyamide 6/6 | 12 | Withdrawn |
| M0790015 | Length 45.00 cm | 6 | Withdrawn |
| G0780103 | Thread Material : polyamide 6/6 | 12 | Withdrawn |
| B0780090 | Thread Material : polyamide 6/6 | 24 | Withdrawn |
| B0780005 | Length 45.00 cm | 24 | Withdrawn |
| B0780017 | Size of Thread (USP – Others) : 0 | 24 | Withdrawn |
| M0790165 | Size of Thread (USP – Others) : 4/0 | 6 | Withdrawn |
| M0790276 | Thread Material : polyamide 6/6 | 6 | 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
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.