Reli
REDILON Monofilament Polyamide (Nylon), Black, 3-0, MFS-1
3manufacturers in China registered for this device type
61catalogue 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 | Myco Medical Supplies, Inc., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| 510(k) | K172149 |
| Record published | 2015-10-24 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Recommended to be stored below 86°F (30°C), away from moisture and direct heat. |
| Packaging | Case of 30, inner carton of 12 |
| Sizes | Length 10 to 30 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N663-SI | Length 18 in | In distribution |
| N1665-M | Length 18 in | In distribution |
| N667-SI | Length 10 in | In distribution |
| N668-30L-M | Length 30 in | In distribution |
| N663-M | Length 18 in | In distribution |
| N698-P | Length 18 in | In distribution |
| N1666-P | Length 18 in | In distribution |
| N697-SI | Length 18 in | In distribution |
| N1698-SI | Length 18 in | In distribution |
| N662-SI | Length 18 in | In distribution |
| N1667-SI | Length 18 in | In distribution |
| N1667-P | Length 18 in | In distribution |
| N664-30L-MV | Length 30 in | In distribution |
| N1667-M | Length 18 in | In distribution |
| N698-M | Length 18 in | In distribution |
| N928-SI | Length 18 in | In distribution |
| N6621-M | 4-0 | In distribution |
| N1665-SI | Length 18 in | In distribution |
| N931-SI | Length 10 in | In distribution |
| N1666-SI | Length 18 in | In distribution |
| N6681-SI | Length 10 in | In distribution |
| N697-P | Length 18 in | In distribution |
| N1663-M | Length 18 in | In distribution |
| N698-SI | Length 18 in | In distribution |
| N663-P | Length 18 in | In distribution |
| N663-30L-MV | Length 30 in | In distribution |
| N662-M | Length 18 in | In distribution |
| N1668-SI | Length 18 in | In distribution |
| N668-M | Length 18 in | In distribution |
| N699-P | Length 18 in | In distribution |
| N931-M | Length 10 in | In distribution |
| N6621-P | Length 10 in | In distribution |
| N699-M | Length 18 in | In distribution |
| N661-M | Length 18 in | In distribution |
| N697-M | Length 18 in | In distribution |
| N661-30L-M | Length 30 in | In distribution |
| N1666-M | Length 18 in | In distribution |
| N913-M | Length 10 in | In distribution |
| N928-M | Length 18 in | In distribution |
| N668-SI | Length 18 in | In distribution |
| N661-30L-SI | Length 30 in | In distribution |
| N699-SI | Length 18 in | In distribution |
| N664-SI | Length 18 in | In distribution |
| N1698-M | Length 18 in | In distribution |
| N9000-MP | Length 12 in | In distribution |
| N931-P | Length 10 in | In distribution |
| N667-M | Length 18 in | In distribution |
| N1698-P | Length 18 in | In distribution |
| N1663-SI | Length 18 in | In distribution |
| N1668-M | Length 18 in | In distribution |
| N668-30L-SI | Length 30 in | In distribution |
| N6681-P | Length 10 in | In distribution |
| N661-P | Length 18 in | In distribution |
| N660-SI | Length 18 in | In distribution |
| N661-SI | Length 18 in | In distribution |
| N6681-M | Length 10 in | In distribution |
| N6621-SI | Length 10 in | In distribution |
| N660-M | Length 18 in | In distribution |
| N1663-P | Length 18 in | In distribution |
| N662-P | Length 18 in | In distribution |
| N664-M | Length 18 in | 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.