Fssb Nylon Suture
39 catalogue numbers from A023PA, listed by Fssb Chirurgische Nadeln GmbH, United States, under Suture, Nonabsorbable, Synthetic, Polyamide. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
39catalogue 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 | Fssb Chirurgische Nadeln GmbH, United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Record published | 2016-09-21 |
| 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 |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A023PA | USP 10/0, Suture Length 38 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| XNBDH8D | USP 8/0; Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| G028PA | USP 9/0, Suture Length 13 cm; Curvature H (1/2 C); Form DS; Length 4 mm; Diameter 100 | 12 | In distribution |
| 7770AE | USP 10/0; Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,2 mm; Diameter 150 | 12 | In distribution |
| E023PA | USP 9/0, Suture Length 15 cm; Curvature D (3/8 C); Form RS; Length 5 mm; Diameter 100 | 12 | In distribution |
| 7718AE | USP 10/0; Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZL; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| 7756AE | USP 10/0, Suture Length 30 cm; Curvature 2xH (1/2 C); Form LZ; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| FD007PA | USP 6/0; Suture Length 45 cm; Curvature D (3/8 C); Form DK; Length 9,5 mm; Diameter 200 | 12 | In distribution |
| FA023PA | USP 10/0, Suture Length 38 cm; Curvature 2xD (3/4 C); Form LZ; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| 2534AE | USP 10/0; Suture Length 15 cm; Curvature H (1/2 C); Form LZ; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| N9000 | USP 10/0, Suture Length 30 cm; Curvature 2xH (1/2 C); Form LZ; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| E028PA | USP 8/0, Suture Length 15 cm; Curvature D (3/8 C); Form RS; Length 6,4 mm; Diameter 150 | 12 | In distribution |
| 0819AE | USP 9/0, Suture Length 13 cm; Curvature V (1/4 C); Form DS; Length 4,0 mm; Diameter 100 | 12 | In distribution |
| A017PA | USP 9/0, Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,2 mm; Diameter 150 | 12 | In distribution |
| 2687AE | USP 10/0, Suture Length 15 cm; Curvature B ; Form LZ; Length 5 mm; Diameter 150 | 12 | In distribution |
| A025PA | USP 10/0, Suture Length 30 cm; Curvature D (3/8 C); Form LZ; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| 2681AE | USP 9/0, Suture Length 15 cm; Curvature H (1/2 C); Form LZ; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| 2510AE | USP 10/0, Suture Length 30 cm; Curvature H (1/2 C); Form LZ; Length5,6 mm; Diameter 150 | 12 | In distribution |
| 2683AE | USP 10/0, Suture Length 15 cm; Curvature D (3/4 C); Form LZ; Length 6,2 mm; Diameter 150 | 12 | In distribution |
| G029PA | USP 9/0, Suture Length 6,5 cm; Curvature D (3/8 C); Form DS; Length 5 mm; Diameter 100 | 12 | In distribution |
| A131PA | USP 9/0, Suture Length 13 cm; Curvature H (1/2 C); Form LZ; Length 6 mm; Diameter 110 | 12 | In distribution |
| N7770 | USP 10/0, Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZS; Length 6,2 mm; Diameter 150 | 12 | In distribution |
| 9000AE | USP 10/0, Suture Length 30 cm; Curvature 2xH (1/2 C); Form LZL; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| 1825AE | USP 9/0, Suture Length 13 cm; Curvature H (1/2 C), Form LZ, Length 6 mm, Diameter 100 | 12 | In distribution |
| N2534 | USP 10/0, Suture Length 15 cm; Curvature H (1/2 C); Form LZS; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| N9003 | USP 10/0, Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,2 mm; Diameter 150 | 12 | In distribution |
| YNBDH8D | USP 9/0; Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| 9061AE | USP 10/0, Suture Length 10 cm; Curvature H (1/2 C); Form LZL; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| 9001AE | USP 10/0, Suture Length 15 cm; Curvature 2xH (1/2 C); Form LZL; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| G030PA | USP 10/0, Suture Length 2,5 cm; Curvature 2xB ; Form DS; Length 5 mm; Diameter 85 | 12 | In distribution |
| G016PA | USP 10/0, Suture Length 15 cm; Curvature D (3/8 C); Form DS; Length 4 mm; Diameter 70 | 12 | In distribution |
| A016PA | USP 10/0, Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,2 mm; Diameter 150 | 12 | In distribution |
| N9061 | USP 10/0, Suture Length 10 cm; Curvature H (1/2 C); Form LZ; Length 5,6 mm; Diameter 150 | 12 | In distribution |
| E013PA | USP 11/0, Suture Length 10 cm; Curvature D (3/8 C); Form RS; Length 3,5 mm; Diameter 50 | 12 | In distribution |
| 2525AE | USP 10/0; Suture Length 30 cm; Curvature B ; Form LZ; Length 5 mm; Diameter 150 | 12 | In distribution |
| WNBD28D | USP 7/0; Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 8,0 mm; Diameter 200 | 12 | In distribution |
| A021PA | USP 9/0, Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| A026PA | USP 10/0, Suture Length 30 cm; Curvature 2xD (3/8 C); Form LZ; Length 6,4 mm; Diameter 200 | 12 | In distribution |
| FA021PA | USP 9/0, Suture Length 30 cm; Curvature 2xD (3/8 C), Form LZ, Length 6,4 mm, Diameter 200 | 12 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060471 | 2006-07-26 |
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.