Suture, Nonabsorbable, Synthetic, Polyamide
15 M 43 DA 10-0 Lancet Point, flat 10-0, Nylon black, 30 cm, sterile double armed, Box with 12 sutures
3manufacturers in China registered for this device type
30catalogue 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 | S & T AG, Switzerland |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Manufacturer |
| Record published | 2016-09-24 |
| 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 |
| Storage | Special storage condition: Do not use if package is damaged; Storage environment temperature 10 to 30 °C; Special storage condition: Do not re-sterilise; Special storage condition: Protect from moisture; Special storage condition: Protect from direct sunlight |
| Packaging | Pack of 12 |
| Sizes | Length 10 to 30 cm |
| Distribution end date | 2020-03-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Surgical suture nonabsorbable monofil Taper Point | Length 10 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | USP 9-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | USP 8-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Lancet Point flat | Length 30 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | USP 10-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | USP 9-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | Length 10 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | USP 8-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Lancet Point flat | USP 10-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | Length 10 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | USP 10-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | USP 9-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | USP 9-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | USP 10-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | USP 11-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Lancet Point flat | Length 30 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | USP 10-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | USP 11-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | Length 10 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Lux | Length 15 cm | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | USP 12-0 | Withdrawn |
| Surgical suture nonabsorbable monofil Taper Point | Length 15 cm | 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 |
|---|---|
| K031531 | 2003-09-23 |
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.