Monomid
49 catalogue numbers from 1629B, listed by C P Medical Inc., 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 | C P Medical Inc. |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Record published | 2015-12-21 |
| Record revised | 2021-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1629B | In distribution | |
| 1663B | In distribution | |
| 691B | In distribution | |
| 628B | In distribution | |
| 919B | In distribution | |
| 928B | In distribution | |
| 593B | In distribution | |
| 697B | In distribution | |
| 1666B | In distribution | |
| 665B | In distribution | |
| 660B | In distribution | |
| 1893B | In distribution | |
| 690B | In distribution | |
| 661B | In distribution | |
| 665M | In distribution | |
| 1864B | In distribution | |
| 663B | In distribution | |
| 668B | In distribution | |
| 669B | In distribution | |
| 662M | In distribution | |
| 1098B | In distribution | |
| 667B | In distribution | |
| 1273B | In distribution | |
| 1696B | In distribution | |
| 1698B | In distribution | |
| 664M | In distribution | |
| 1669B | In distribution | |
| 931B | In distribution | |
| 627B | In distribution | |
| 664B | In distribution | |
| 1667B | In distribution | |
| 944B | In distribution | |
| 915B | In distribution | |
| 662B | In distribution | |
| 795B | In distribution | |
| 1668B | In distribution | |
| 699B | In distribution | |
| 913B | In distribution | |
| 1865B | In distribution | |
| 945B | In distribution | |
| 663M | In distribution | |
| 1856B | In distribution | |
| 911B | In distribution | |
| 1665B | In distribution | |
| 1099B | In distribution | |
| 1855B | In distribution | |
| 698B | In distribution | |
| 738B | In distribution | |
| 1674B | 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 |
| 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-06-29 | Not classified | Process control | Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material. | 776 dozens boxes | 2012-05-24 |
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.