Dafilon
Dafilon Blue 6/0 (0,7) 45CM DS12 (M) DDP
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 | 2015-08-16 |
| Record revised | 2026-03-31 (version 19) |
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, carton of 60 |
| Sizes | Length 3 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C0932493 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0935190 | Thread Material : polyamide | 36 | Withdrawn |
| C0930165 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0934429 | Thread Material : polyamide | 36 | Withdrawn |
| C0930010 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| G0933066 | Length 45.0 cm | 12 | Withdrawn |
| B0938905 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| B0934224 | Length 100.0 cm | 24 | Withdrawn |
| G1118706 | Thread Material : polyamide | 12 | Withdrawn |
| B0935584 | Thread Material : polyamide | 24 | Withdrawn |
| C0932779 | Thread Material : polyamide | 36 | Withdrawn |
| C0934801 | Length 90.00 cm | 36 | Withdrawn |
| C0930760 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0933392 | Length 75.00 cm | 36 | Withdrawn |
| C0934570 | Thread Material : polyamide | 36 | Withdrawn |
| G0934054 | Thread Material : polyamide | 12 | Withdrawn |
| G1111434 | Length 15.00 cm | 12 | Withdrawn |
| C0431249 | Thread Material : polyamide | 36 | Withdrawn |
| C0916155 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0935115 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C0936227 | Thread Material : polyamide | 36 | Withdrawn |
| G0930105 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| B0931641 | Length 75.0 cm | 24 | Withdrawn |
| B0935905 | Thread Material : polyamide | 24 | Withdrawn |
| G0936081 | Length 45.00 cm | 12 | Withdrawn |
| C0912247 | Length 45.00 cm | 36 | Withdrawn |
| C0935859 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0916022 | Length 75.00 cm | 36 | Withdrawn |
| G1118447 | Length 3.00 cm | 12 | Withdrawn |
| G0934585 | Length 100.0 cm | 12 | Withdrawn |
| B0436536 | Thread Material : polyamide | 24 | Withdrawn |
| G1118471 | Thread Material : polyamide | 12 | Withdrawn |
| C0936316 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0930741 | Length 75.00 cm | 36 | Withdrawn |
| C0936511 | Thread Material : polyamide | 36 | Withdrawn |
| B0436537 | Length 45.0 cm | 24 | Withdrawn |
| B0930750 | Length 75.0 cm | 24 | Withdrawn |
| G0932280 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| X0977225 | Size of Thread (USP – Others) : 7/0 | 4 | Withdrawn |
| B0935769 | Thread Material : polyamide | 24 | Withdrawn |
| G0935620 | Thread Material : polyamide | 12 | Withdrawn |
| C0930004 | Length 120.0 cm | 36 | Withdrawn |
| G0936740 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0935107 | Length 75.00 cm | 36 | Withdrawn |
| C0936593 | Length 60.0 cm | 36 | Withdrawn |
| G0932574 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C0932124 | Thread Material : polyamide | 36 | Withdrawn |
| C0934054 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G1118757 | Length 30.00 cm | 12 | Withdrawn |
| G1118080 | Length 10.00 cm | 12 | Withdrawn |
| C0932998 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G1118738 | Size of Thread (USP – Others) : 9/0 | 12 | Withdrawn |
| C0930423 | Thread Material : polyamide | 36 | Withdrawn |
| C0935590 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| B0932769 | Size of Thread (USP – Others) : 0 | 24 | Withdrawn |
| G0932213 | Length 45.00 cm | 12 | Withdrawn |
| C0935654 | Length 90.00 cm | 36 | Withdrawn |
| G1118633 | Thread Material : polyamide | 12 | Withdrawn |
| B0436503 | Thread Material : polyamide | 24 | Withdrawn |
| C0916626 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0934925 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C0936618 | Thread Material : polyamide | 36 | Withdrawn |
| G1118032 | Length 30.00 cm | 12 | Withdrawn |
| C0933201 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0932116 | Thread Material : polyamide | 36 | Withdrawn |
| B0436538 | Size of Thread (USP – Others) : 3 | 24 | Withdrawn |
| C0932736 | Thread Material : polyamide | 36 | Withdrawn |
| C0934004 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G0935379 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| B0932191 | Size of Thread (USP – Others) : 5/0 | 24 | Withdrawn |
| C0432075 | Length 150.0 cm | 36 | Withdrawn |
| C0930008 | Thread Material : polyamide | 36 | Withdrawn |
| C0935000 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0932078 | Size of Thread (USP – Others) : 5/0 | 24 | Withdrawn |
| B0932116 | Thread Material : polyamide | 24 | Withdrawn |
| C0932566 | Thread Material : polyamide | 36 | Withdrawn |
| C0936090 | Thread Material : polyamide | 36 | Withdrawn |
| G0936316 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0935344 | Length 75.00 cm | 36 | Withdrawn |
| C0436275 | Length 45.0 cm | 36 | Withdrawn |
| C0932545 | Length 45.0 cm | 36 | Withdrawn |
| B0933589 | Length 150.0 cm | 24 | Withdrawn |
| C0936162 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0934008 | Length 45.0 cm | 36 | Withdrawn |
| C0935042 | Length 60.0 cm | 36 | Withdrawn |
| C0934224 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0934006 | Thread Material : polyamide | 36 | Withdrawn |
| C0432067 | Thread Material : polyamide | 36 | Withdrawn |
| C0933906 | Length 45.0 cm | 36 | Withdrawn |
| C0932612 | Thread Material : polyamide | 36 | Withdrawn |
| C0935336 | Thread Material : polyamide | 36 | Withdrawn |
| B0934844 | Thread Material : polyamide | 24 | Withdrawn |
| C0935360 | Length 75.00 cm | 36 | Withdrawn |
| C0935352 | Thread Material : polyamide | 36 | Withdrawn |
| C0935468 | Length 75.00 cm | 36 | Withdrawn |
| C0932221 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0916043 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0935352 | Thread Material : polyamide | 12 | Withdrawn |
| C0916165 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0935677 | Length 75.0 cm | 36 | Withdrawn |
| G1110020 | Length 15.00 cm | 12 | Withdrawn |
| C0935239 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0932850 | Thread Material : polyamide | 36 | Withdrawn |
| C0930482 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0938920 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0930104 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| B0436658 | Length 45.0 cm | 24 | Withdrawn |
| C0935255 | Thread Material : polyamide | 36 | Withdrawn |
| B0934518 | Length 150.0 cm | 24 | Withdrawn |
| G0934003 | Length 90.0 cm | 12 | Withdrawn |
| C0934579 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| G0933139 | Thread Material : polyamide | 12 | Withdrawn |
| C0938248 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C0916055 | Thread Material : polyamide | 36 | Withdrawn |
| C0936154 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0933911 | Length 45.0 cm | 12 | Withdrawn |
| C0935963 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0935910 | Size of Thread (USP – Others) : 2 | 24 | Withdrawn |
| G0938210 | Length 45.0 cm | 12 | Withdrawn |
| C0935310 | Thread Material : polyamide | 36 | Withdrawn |
| C0935002 | Thread Material : polyamide | 36 | Withdrawn |
| G0933903 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C0931056 | Length 90.0 cm | 36 | Withdrawn |
| B0930628 | Length 100.0 cm | 24 | Withdrawn |
| C0934020 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G0932345 | Thread Material : polyamide | 12 | Withdrawn |
| C0935247 | Thread Material : polyamide | 36 | Withdrawn |
| B0935360 | Size of Thread (USP – Others) : 2/0 | 24 | Withdrawn |
| G0936243 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0936294 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G1118838 | Size of Thread (USP – Others) : 10/0 | 12 | Withdrawn |
| C0932647 | Length 75.00 cm | 36 | Withdrawn |
| C0935069 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0934828 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0935484 | Thread Material : polyamide | 36 | Withdrawn |
| G1118138 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C0934038 | Thread Material : polyamide | 36 | Withdrawn |
| C0935573 | Length 90.00 cm | 36 | Withdrawn |
| G1118560 | Thread Material : polyamide | 12 | Withdrawn |
| G1118420 | Thread Material : polyamide | 12 | Withdrawn |
| C0934003 | Length 90.00 cm | 36 | Withdrawn |
| C0936081 | Thread Material : polyamide | 36 | Withdrawn |
| G1118161 | Size of Thread (USP – Others) : 9/0 | 12 | Withdrawn |
| G1118889 | Length 15.0 cm | 12 | Withdrawn |
| C0934007 | Length 75.0 cm | 36 | Withdrawn |
| C0431265 | Length 100.0 cm | 36 | Withdrawn |
| G1118790 | Length 15.00 cm | 12 | Withdrawn |
| G1117041 | Thread Material : polyamide | 12 | Withdrawn |
| C0932191 | Thread Material : polyamide | 36 | Withdrawn |
| G0930182 | Thread Material : polyamide | 12 | Withdrawn |
| B0933570 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0933112 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G0936014 | Length 45.0 cm | 12 | Withdrawn |
| C0936839 | Length 75.0 cm | 36 | Withdrawn |
| C0934005 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G1110326 | Length 30.00 cm | 12 | Withdrawn |
| B0935890 | Thread Material : polyamide | 24 | Withdrawn |
| C0932507 | Thread Material : polyamide | 36 | Withdrawn |
| C0934860 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G0932620 | Thread Material : polyamide | 12 | Withdrawn |
| C0934836 | Thread Material : polyamide | 36 | Withdrawn |
| C0932272 | Thread Material : polyamide | 36 | Withdrawn |
| C0934976 | Thread Material : polyamide | 36 | Withdrawn |
| C0935181 | Thread Material : polyamide | 36 | Withdrawn |
| C0938106 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C0933368 | Thread Material : polyamide | 36 | Withdrawn |
| C0932280 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0935131 | Length 75.00 cm | 36 | Withdrawn |
| C0431257 | Length 100.0 cm | 36 | Withdrawn |
| G0932140 | Length 45.0 cm | 12 | Withdrawn |
| G1118129 | Thread Material : polyamide | 12 | Withdrawn |
| B0932213 | Size of Thread (USP – Others) : 3/0 | 24 | Withdrawn |
| C0932710 | Length 75.00 cm | 36 | Withdrawn |
| C0932540 | Thread Material : polyamide | 36 | Withdrawn |
| G0935492 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C0936146 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| B0934710 | Length 150.0 cm | 24 | Withdrawn |
| C0932582 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0933907 | Thread Material : polyamide | 12 | Withdrawn |
| C0933210 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0436535 | Size of Thread (USP – Others) : 0 | 24 | Withdrawn |
| G0933244 | Thread Material : polyamide | 12 | Withdrawn |
| G0936235 | Length 45.00 cm | 12 | Withdrawn |
| G0934038 | Thread Material : polyamide | 12 | Withdrawn |
| C0933901 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0932086 | Length 45.00 cm | 36 | Withdrawn |
| B0934579 | Size of Thread (USP – Others) : 2 | 24 | Withdrawn |
| C0936251 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| B0436674 | Thread Material : polyamide | 24 | Withdrawn |
| C0934968 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0935964 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0932477 | Thread Material : polyamide | 12 | Withdrawn |
| C0938905 | Length 100.0 cm | 36 | Withdrawn |
| G0935344 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C0930003 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G1118374 | Length 8.0 cm | 12 | Withdrawn |
| G1110225 | Size of Thread (USP – Others) : 10/0 | 12 | Withdrawn |
| G0935484 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| B0431303 | Thread Material : polyamide | 24 | Withdrawn |
| G1118030 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C0934691 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0936122 | Length 45.0 cm | 36 | Withdrawn |
| G1110740 | Thread Material : polyamide | 12 | Withdrawn |
| C0936650 | Length 75.0 cm | 36 | Withdrawn |
| G0936820 | Length 75.0 cm | 12 | Withdrawn |
| G1111213 | Size of Thread (USP – Others) : 11/0 | 12 | Withdrawn |
| C0936280 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C0936324 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0936324 | Length 45.00 cm | 12 | Withdrawn |
| C0916034 | Length 75.00 cm | 36 | Withdrawn |
| C0932650 | Thread Material : polyamide | 36 | Withdrawn |
| B0930005 | Length 120.0 cm | 24 | Withdrawn |
| B0934713 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0936243 | Thread Material : polyamide | 36 | Withdrawn |
| C0936378 | Thread Material : polyamide | 36 | Withdrawn |
| G1111140 | Size of Thread (USP – Others) : 9/0 | 12 | Withdrawn |
| C0930970 | Thread Material : polyamide | 36 | Withdrawn |
| C0932787 | Thread Material : polyamide | 36 | Withdrawn |
| C0930011 | Length 120.0 cm | 36 | Withdrawn |
| C0930962 | Length 75.0 cm | 36 | Withdrawn |
| G0932850 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| B0934001 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| G1111922 | Size of Thread (USP – Others) : 10/0 | 12 | Withdrawn |
| C0932784 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0938505 | Length 90.0 cm | 36 | Withdrawn |
| C0932370 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G1118331 | Length 7.00 cm | 12 | Withdrawn |
| C0916054 | Length 75.00 cm | 36 | Withdrawn |
| B0932574 | Thread Material : polyamide | 24 | Withdrawn |
| C0935204 | Length 75.00 cm | 36 | Withdrawn |
| C0916144 | Thread Material : polyamide | 36 | Withdrawn |
| C0930009 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0935050 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| B0436534 | Size of Thread (USP – Others) : 2/0 | 24 | Withdrawn |
| G0935204 | Length 75.00 cm | 12 | Withdrawn |
| G0930628 | Thread Material : polyamide | 12 | Withdrawn |
| C0932876 | Length 90.00 cm | 36 | Withdrawn |
| B0436533 | Length 45.0 cm | 24 | Withdrawn |
| C0932477 | Thread Material : polyamide | 36 | Withdrawn |
| C0933905 | Thread Material : polyamide | 36 | Withdrawn |
| G0934968 | Thread Material : polyamide | 12 | Withdrawn |
| C0933244 | Length 75.0 cm | 36 | Withdrawn |
| C0930750 | Length 75.0 cm | 36 | Withdrawn |
| G0932132 | Thread Material : polyamide | 12 | Withdrawn |
| B0935915 | Thread Material : polyamide | 24 | Withdrawn |
| B0934552 | Thread Material : polyamide | 24 | Withdrawn |
| G0934658 | Thread Material : polyamide | 12 | Withdrawn |
| G1118528 | Size of Thread (USP – Others) : 10/0 | 12 | Withdrawn |
| G1118250 | Size of Thread (USP – Others) : 10/0 | 12 | Withdrawn |
| G1118862 | Length 30.00 cm | 12 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| 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 |
| Trelon | B Braun Surgical SA | 72 |
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.