Supramid
1/2 Circle Reverse Cutting Double-Arm Needle (12.7mm), USP 6-0 SUPRAMID black monofilament Nylon, 12"
3manufacturers in China registered for this device type
64catalogue numbers in this listing
4510(k) clearances naming 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 | S. Jackson, Inc., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Manufacturer |
| Record published | 2017-07-20 |
| Record revised | 2021-02-05 (version 5) |
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 |
| Packaging | Box of 12, pack of 12 |
| Distribution end date | 2016-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Code MEA-50B | In distribution | |
| Code MRC-50B | In distribution | |
| Code MOS-60B-36 | In distribution | |
| Code MPL-30B | In distribution | |
| Code MRL-60B | In distribution | |
| Code MPL-40B-60 | In distribution | |
| Code MPL-40B | In distribution | |
| Code 2S-1-50 | In distribution | |
| Code MSB-60B | In distribution | |
| Code MPR-40 | In distribution | |
| Code 2MLC-60B | In distribution | |
| Code MER-30B | In distribution | |
| Code MSB-50B | In distribution | |
| Code MOS-40B | In distribution | |
| Code MPR-60B-36 | In distribution | |
| Code MPR-50B | In distribution | |
| Code LCW-50-20 | In distribution | |
| Code 2MEA-50 | In distribution | |
| Code 2MOS-50 | In distribution | |
| Code MEE-60B | In distribution | |
| Code MOS-60B | In distribution | |
| Code MPL-40B-67 | In distribution | |
| Code MLA-40B | In distribution | |
| Code MPR-40B-36 | In distribution | |
| Code MRL-50B | In distribution | |
| Code MER-40 | In distribution | |
| Code MLC-50 | In distribution | |
| Code MPR-30B-36 | In distribution | |
| Code MEE-50W | In distribution | |
| Code MLC-50B | In distribution | |
| Code MPR-30 | In distribution | |
| Code MPR-40B | In distribution | |
| Code MEA-60B | In distribution | |
| Code MEA-40B | In distribution | |
| Code LHR-50 | In distribution | |
| Code MDB-60B | In distribution | |
| Code MDB-40B | In distribution | |
| Code MSB-50B-18 | In distribution | |
| Code MLA-50B | In distribution | |
| Code LCW-50 | In distribution | |
| Code MDB-40B-18 | In distribution | |
| Code MOS-50B | In distribution | |
| Code MDB-50B | In distribution | |
| Code MPL-40B-18 | In distribution | |
| Code MPR-60B | In distribution | |
| Code MPL-40B-27 | In distribution | |
| Code MPR-50 | In distribution | |
| Code MLC-60B | In distribution | |
| Code MPL-40B-70 | In distribution | |
| Code MRL-40B | In distribution | |
| Code MPR-30B | In distribution | |
| Code MLA-60B | In distribution | |
| Code MPL-20B | In distribution | |
| Code MER-40B | In distribution | |
| Code MPR-50B-36 | In distribution | |
| Code 2MLC-50 | In distribution | |
| Code MDB-30B | In distribution | |
| Code MOS-40 | In distribution | |
| Code MSB-40B | In distribution | |
| Code MFT-30B | In distribution | |
| Code MEE-50B | In distribution | |
| Code MEA-50 | In distribution | |
| Code MOS-50 | In distribution | |
| 2S-1-50 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K931612 | 1993-12-17 |
| K931613 | 1993-12-17 |
| K912429 | 1991-10-02 |
| K904052 | 1990-10-25 |
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.