Mani Sutures Nylon
88 catalogue numbers from 1421, listed by Mani, Inc., United States, under Suture, Nonabsorbable, Synthetic, Polyamide. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
88catalogue numbers in this listing
1510(k) clearance
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 | Mani, Inc., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Record published | 2016-06-04 |
| Record revised | 2021-10-18 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1421 | Needle Length 5.5mm | In distribution |
| 1053S | Needle Length 4.0mm | In distribution |
| 2865 | Needle Length 7.0mm | In distribution |
| 1403 | Needle Length 5.5mm | In distribution |
| 2808S | Needle Length 13.0mm | In distribution |
| 1401 | Suture Length 30cm | In distribution |
| 2856 | Needle Length 8.0mm | In distribution |
| 3388 | Needle Length 15.0mm | In distribution |
| 1000S | Suture Length 10cm | In distribution |
| 1452 | Needle Length 6.0mm | In distribution |
| 1000 | Needle Length 5.5mm | In distribution |
| 0550S | Needle Length 4.0mm | In distribution |
| 38 | In distribution | |
| 3379S | Needle Length 7.0mm | In distribution |
| 1402 | Needle Length 5.0mm | In distribution |
| 2054 | Needle Length 6.5mm | In distribution |
| 3363S | Needle Length 13.0mm | In distribution |
| 39 | In distribution | |
| 1410S | Needle Length 7.0mm | In distribution |
| 1476 | Needle Length 5.5mm | In distribution |
| 2808 | Needle Length 13.0mm | In distribution |
| 1052S | Needle Length 5.0mm | In distribution |
| 3382S | Suture Length 45cm | In distribution |
| 3386 | Needle Length 15.0mm | In distribution |
| 3381S | Needle Length 11.0mm | In distribution |
| 1407 | Needle Length 6.0mm | In distribution |
| 2002 | Needle Length 6.5mm | In distribution |
| 21 | In distribution | |
| 2807 | Needle Length 6.0mm | In distribution |
| 23 | In distribution | |
| 1410 | Needle Length 7.0mm | In distribution |
| 3361S | Needle Length 8.0mm | In distribution |
| 2859 | Needle Length 8.0mm | In distribution |
| 3361 | Needle Length 8.0mm | In distribution |
| 3364 | Needle Length 11.0mm | In distribution |
| 1482 | Needle Length 5.5mm | In distribution |
| 7 | In distribution | |
| 13 | In distribution | |
| 1406 | Suture Length 30cm | In distribution |
| 2058 | Needle Length 6.5mm | In distribution |
| 1404 | Needle Length 5.5mm | In distribution |
| 3383S | Needle Length 11.0mm | In distribution |
| 1401S | Needle Length 5.0mm | In distribution |
| 2455S | Needle Length 7.0mm | In distribution |
| 18 | In distribution | |
| 2028 | Needle Length 7.0mm | In distribution |
| 1478S | Needle Length 6.0mm | In distribution |
| 2806 | Needle Length 6.0mm | In distribution |
| 1459S | Suture Length 13cm | In distribution |
| 19 | In distribution | |
| 2002S | Needle Length 6.5mm | In distribution |
| 31 | In distribution | |
| 12 | In distribution | |
| 3387 | Needle Length 11.0mm | In distribution |
| 2461 | Needle Length 11.0mm | In distribution |
| 2056 | Needle Length 6.5mm | In distribution |
| 2854 | Needle Length 8.0mm | In distribution |
| 1404S | Needle Length 5.5mm | In distribution |
| 32 | In distribution | |
| 2003 | Needle Length 6.5mm | In distribution |
| 1001 | Needle Length 5.5mm | In distribution |
| 35 | In distribution | |
| 2003S | Needle Length 6.5mm | In distribution |
| 1457 | Needle Length 5.5mm | In distribution |
| 1406S | Needle Length 6.0mm | In distribution |
| 2855 | Needle Length 8.0mm | In distribution |
| 2000 | Needle Length 5.5mm | In distribution |
| 15 | In distribution | |
| 16 | In distribution | |
| 3853S | Needle Length 11.0mm | In distribution |
| 36 | In distribution | |
| 1407S | Needle Length 6.0mm | In distribution |
| 1459 | Needle Length 6.0mm | In distribution |
| 1474 | Needle Length 5.0mm | In distribution |
| 1475 | Needle Length 5.5mm | In distribution |
| 1468S | Needle Length 6.0mm | In distribution |
| 2457S | Needle Length 9.0mm | In distribution |
| 3364S | Suture Length 50cm | In distribution |
| 2461S | Needle Length 11.0mm | In distribution |
| 33 | In distribution | |
| 40 | In distribution | |
| 1405 | Needle Length 5.5mm | In distribution |
| 3362S | Needle Length 8.0mm | In distribution |
| 3365 | Needle Length 15.0mm | In distribution |
| 3854 | Needle Length 11.0mm | In distribution |
| 3382 | Needle Length 11.0mm | In distribution |
| 2463 | Needle Length 11.0mm | In distribution |
| 3854S | Needle Length 11.0mm | In distribution |
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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053637 | 2006-05-19 |
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.