Cardionyl®
58 catalogue numbers from 72029FH23, listed by Peters Surgical, France, under Suture, Nonabsorbable, Synthetic, Polyamide. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
58catalogue 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 | Peters Surgical, France |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| 510(k) | K913102 |
| Record published | 2020-01-09 |
| Record revised | 2023-07-12 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72029FH23 | In distribution | |
| 721222 | In distribution | |
| 72025 | In distribution | |
| 721822 | In distribution | |
| 723402 | In distribution | |
| 72K07K | In distribution | |
| 72609 | In distribution | |
| 72177FH23 | In distribution | |
| 721792 | In distribution | |
| 72401 | In distribution | |
| 72019LH28 | In distribution | |
| 720292 | In distribution | |
| 721072 | In distribution | |
| 721212 | In distribution | |
| 72105K2 | In distribution | |
| 72129FH23 | In distribution | |
| 72106KH23 | In distribution | |
| 72413 | In distribution | |
| 721932 | In distribution | |
| 72179K2 | In distribution | |
| 72116R | In distribution | |
| 721942 | In distribution | |
| 720502 | In distribution | |
| 721052 | In distribution | |
| 72106FH23 | In distribution | |
| 72123KH23 | In distribution | |
| 721242 | In distribution | |
| 721202 | In distribution | |
| 72252 | In distribution | |
| 721272 | In distribution | |
| 721812 | In distribution | |
| 72107 | In distribution | |
| 721092 | In distribution | |
| 722662 | In distribution | |
| 72019NH23 | In distribution | |
| 720252 | In distribution | |
| 72253 | In distribution | |
| 72128FH23 | In distribution | |
| 72189R | In distribution | |
| 722522 | In distribution | |
| 72121K2 | In distribution | |
| 72021 | In distribution | |
| 722532 | In distribution | |
| 72179 | In distribution | |
| 721772 | In distribution | |
| 72020K2 | In distribution | |
| 72107K023 | In distribution | |
| 72448 | In distribution | |
| 72487 | In distribution | |
| 722542 | In distribution | |
| 724032 | In distribution | |
| 720202H | In distribution | |
| 72020K23M | In distribution | |
| 72020FH23M | In distribution | |
| 72K10M | In distribution | |
| 720202W | In distribution | |
| 721292 | In distribution | |
| 720212 | 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
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.