A.C.S® (Alcon Closure System)
Suture - Needle Type CUM-15, Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12, Double Armed
3manufacturers in China registered for this device type
34catalogue 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 | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Record published | 2015-10-24 |
| Record revised | 2024-03-22 (version 7) |
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, manufacturing date |
| Packaging | Box of 12 |
| Sizes | Length 6 to 18 in; height 12 in |
| Distribution end date | 2022-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065693001 | Length 12 in | In distribution |
| 8065198001 | Length 12 in | In distribution |
| 8065194101 | Length 12 in | In distribution |
| 8065193001 | Length 12 in | In distribution |
| 8065192001 | Length 6 in | In distribution |
| 8065208101 | Length 12 in | In distribution |
| 8065202101 | Height 12 in | In distribution |
| 8065215501 | Length 18 in | In distribution |
| 8065692101 | Length 12 in | In distribution |
| 8065198101 | Length 12 in | In distribution |
| 8065712101 | Length 12 in | In distribution |
| 8065692001 | Length 6 in | In distribution |
| 8065710001 | Length 6 in | In distribution |
| 8065702001 | Length 8 in | In distribution |
| 8065192101 | Length 12 in | In distribution |
| 8065710401 | Length 6 in | In distribution |
| 8065698001 | Length 12 in | In distribution |
| 8065208001 | Length 12 in | In distribution |
| 8065218601 | Length 12 in | In distribution |
| 8065202001 | Length 8 in | In distribution |
| 8065198501 | Length 6 in | In distribution |
| 8065711701 | Length 12 in | Withdrawn |
| 8065201701 | Length 12 in | Withdrawn |
| 8065702101 | Length 12 in | Withdrawn |
| 8065211501 | Length 18 in | Withdrawn |
| 8065712201 | Length 6 in | Withdrawn |
| 8065201201 | Length 12 in | Withdrawn |
| 8065222101 | Length 12 in | Withdrawn |
| 8065691901 | Length 12 in | Withdrawn |
| 8065693101 | Length 12 in | Withdrawn |
| 8065198201 | Length 12 in | Withdrawn |
| 8065194101 | Length 12 in | Withdrawn |
| 8065192201 | Length 12 in | Withdrawn |
| 8065193101 | Length 12 in | 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 |
|---|---|
| K930517 | 1993-12-17 |
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.