WEGO-Nylon Non-Absorbable Surgical Suture With Needle
279 catalogue numbers from N23373, listed by Foosin Medical Supplies Inc.ltd, China, under Suture, Nonabsorbable, Synthetic, Polyamide. 3 manufacturers in China are registered for this product code.
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 | Foosin Medical Supplies Inc.ltd, China |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Manufacturer |
| 510(k) | K080684 |
| Record published | 2015-10-30 |
| Record revised | 2021-09-20 (version 7) |
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, manufacturing date |
| Packaging | Pack of 12 |
| Distribution end date | 2021-09-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N23373 | In distribution | |
| NC3903 | In distribution | |
| N53243 | In distribution | |
| N11402P | In distribution | |
| N43152 | In distribution | |
| ND4453 | In distribution | |
| N34403 | In distribution | |
| N44193 | In distribution | |
| N36243-45 | In distribution | |
| N13453 | In distribution | |
| N13403 | In distribution | |
| N53162 | In distribution | |
| N41192 | In distribution | |
| N41203 | In distribution | |
| N11372 | In distribution | |
| N43163 | In distribution | |
| N24362 | In distribution | |
| NB1402HP | In distribution | |
| N21312 | In distribution | |
| N47192 | In distribution | |
| N53203 | In distribution | |
| N44243-45 | In distribution | |
| N24403 | In distribution | |
| N53213 | In distribution | |
| N63133 | In distribution | |
| N34303 | In distribution | |
| N13303 | In distribution | |
| N27193 | In distribution | |
| N57222 | In distribution | |
| N11362 | In distribution | |
| N24223 | In distribution | |
| N23600 | In distribution | |
| NB1362 | In distribution | |
| N14303 | In distribution | |
| N43263 | In distribution | |
| N81083 | In distribution | |
| N23202 | In distribution | |
| N14402 | In distribution | |
| N47222 | In distribution | |
| N31243 | In distribution | |
| N63243 | In distribution | |
| N37193 | In distribution | |
| N24550 | In distribution | |
| N23192 | In distribution | |
| N51162 | In distribution | |
| N31352 | In distribution | |
| N21263 | In distribution | |
| N13383 | In distribution | |
| N21262 | In distribution | |
| N41162 | In distribution | |
| NA8063 | In distribution | |
| N23550 | In distribution | |
| N53123 | In distribution | |
| N34263 | In distribution | |
| N66133-45 | In distribution | |
| N43243 | In distribution | |
| N23362 | In distribution | |
| N11402HP | In distribution | |
| NB3382 | In distribution | |
| NB007602 | In distribution | |
| NC6613 | In distribution | |
| N88063D | In distribution | |
| N11482HP | In distribution | |
| N11502HP | In distribution | |
| N41172D | In distribution | |
| N31252 | In distribution | |
| N61153 | In distribution | |
| N17402 | In distribution | |
| N53133 | In distribution | |
| NC3403 | In distribution | |
| N34243 | In distribution | |
| N37222 | In distribution | |
| N34223 | In distribution | |
| N31262 | In distribution | |
| N23203 | In distribution | |
| N43262 | In distribution | |
| NB1402P | In distribution | |
| N23243 | In distribution | |
| N13393 | In distribution | |
| N33263 | In distribution | |
| N47193 | In distribution | |
| N14372 | In distribution | |
| N11302HP | In distribution | |
| N43123 | In distribution | |
| NB1482 | In distribution | |
| N26313 | In distribution | |
| NB1482P | In distribution | |
| GC7502 | In distribution | |
| N24373 | In distribution | |
| N11372P | In distribution | |
| N23193 | In distribution | |
| N13243 | In distribution | |
| N33203 | In distribution | |
| NC3482 | In distribution | |
| N64163 | In distribution | |
| N21302 | In distribution | |
| NC5613 | In distribution | |
| N23183 | In distribution | |
| N23383 | In distribution | |
| N11242 | In distribution | |
| N41182 | In distribution | |
| N33223 | In distribution | |
| N23372 | In distribution | |
| N24243 | In distribution | |
| N33383 | In distribution | |
| N33600 | In distribution | |
| N1007602 | In distribution | |
| N41263 | In distribution | |
| N51163 | In distribution | |
| N53163 | In distribution | |
| N57193 | In distribution | |
| N43183 | In distribution | |
| N53153 | In distribution | |
| N51153 | In distribution | |
| N34193 | In distribution | |
| N23363 | In distribution | |
| N11302 | In distribution | |
| N23303 | In distribution | |
| N46193-75 | In distribution | |
| N33403-75 | In distribution | |
| N21362 | In distribution | |
| N46163-45 | In distribution | |
| N31202 | In distribution | |
| N46193 | In distribution | |
| N33313 | In distribution | |
| N53113 | In distribution | |
| N13363 | In distribution | |
| N51162D | In distribution | |
| N11403 | In distribution | |
| N13313 | In distribution | |
| N24303 | In distribution | |
| N43213 | In distribution | |
| N43193 | In distribution | |
| N43202 | In distribution | |
| N43133 | In distribution | |
| N13402 | In distribution | |
| NA8063D | In distribution | |
| N13382 | In distribution | |
| N41202 | In distribution | |
| N43162 | In distribution | |
| N43193Y | In distribution | |
| N43650-75 | In distribution | |
| N21242 | In distribution | |
| N43153 | In distribution | |
| N33252 | In distribution | |
| N61132 | In distribution | |
| N24263 | In distribution | |
| N73133 | In distribution | |
| N41193 | In distribution | |
| NC4453 | In distribution | |
| N13263 | In distribution | |
| N37192 | In distribution | |
| N14243 | In distribution | |
| N67193 | In distribution | |
| N41190 | In distribution | |
| N33303 | In distribution | |
| N63163 | In distribution | |
| N23393 | In distribution | |
| N56123 | In distribution | |
| N23453 | In distribution | |
| N23273 | In distribution | |
| N43192 | In distribution | |
| N53123D | In distribution | |
| N31193 | In distribution | |
| N34302 | In distribution | |
| N53193 | In distribution | |
| NB1302 | In distribution | |
| N33163 | In distribution | |
| N33193 | In distribution | |
| N21372 | In distribution | |
| N31302 | In distribution | |
| N41162D | In distribution | |
| N56133-45 | In distribution | |
| N33243 | In distribution | |
| N33242 | In distribution | |
| N46163 | In distribution | |
| N34352 | In distribution | |
| N23253 | In distribution | |
| N13373 | In distribution | |
| N23452 | In distribution | |
| N23403 | In distribution | |
| N51202 | In distribution | |
| N23302 | In distribution | |
| N11402 | In distribution | |
| N51152 | In distribution | |
| N41172 | In distribution | |
| N31242 | In distribution | |
| N36263 | In distribution | |
| N73123 | In distribution | |
| N53173 | In distribution | |
| N1006001 | In distribution | |
| N26193 | In distribution | |
| N33133 | In distribution | |
| N43203 | In distribution | |
| N31192 | In distribution | |
| N23263 | In distribution | |
| N88063 | In distribution | |
| N33273 | In distribution | |
| NB1352HP | In distribution | |
| N13372 | In distribution | |
| NB3372 | Withdrawn | |
| G1005006 | Withdrawn | |
| G11222 | Withdrawn | |
| N58084D | Withdrawn | |
| NB3403 | Withdrawn | |
| NB3313 | Withdrawn | |
| G11252H | Withdrawn | |
| G1015001 | Withdrawn | |
| NC3402 | Withdrawn | |
| G1007002 | Withdrawn | |
| NB3402 | Withdrawn | |
| G1006005 | Withdrawn | |
| G11402 | Withdrawn | |
| NB3353 | Withdrawn | |
| NB1502HP | Withdrawn | |
| G11265D | Withdrawn | |
| NC1302 | Withdrawn | |
| NB1502P | Withdrawn | |
| NB3903 | Withdrawn | |
| G11302H | Withdrawn | |
| NB1302P | Withdrawn | |
| NB3452 | Withdrawn | |
| NB1502 | Withdrawn | |
| G11262U | Withdrawn | |
| G1025001 | Withdrawn | |
| NC3303 | Withdrawn | |
| NB3362 | Withdrawn | |
| NB3393 | Withdrawn | |
| N61103D | Withdrawn | |
| N81063 | Withdrawn | |
| NB1352 | Withdrawn | |
| G1006010 | Withdrawn | |
| G11372 | Withdrawn | |
| NB7402P | Withdrawn | |
| G1009001 | Withdrawn | |
| G1006001 | Withdrawn | |
| N63193 | Withdrawn | |
| N63123 | Withdrawn | |
| NB1372P | Withdrawn | |
| N66163 | Withdrawn | |
| G11302 | Withdrawn | |
| NB3753 | Withdrawn | |
| N61202 | Withdrawn | |
| NC1372 | Withdrawn | |
| N98063 | Withdrawn | |
| G1007005 | Withdrawn | |
| G11265 | Withdrawn | |
| NB4903 | Withdrawn | |
| G1005006 | Withdrawn | |
| NB1372 | Withdrawn |
Showing 250 of 279 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| Dafilon | B Braun Surgical SA | 592 |
| 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.