AROSuture Sterile
AROSuture-Sterile 7-0, 3/8 circle, 18 inches, 11mm, Precision reverse cutting, Box/12
3manufacturers in China registered for this device type
31catalogue 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 | Aros Surgical Instruments Corporation, United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-11-18 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SP24A03N-45 | Thread Diameter 0.2mm | 12 | In distribution |
| CC11A07N-45 | Needle Length 11mm | 12 | In distribution |
| SP19A03N-45 | Thread Diameter 0.2mm | 12 | In distribution |
| CC13A05N-45 | Needle Length 13mm | 12 | In distribution |
| E13A05N-45 | Thread Diameter 0.1mm | 12 | In distribution |
| E13A05L-45 | Thread Diameter 0.1mm | 12 | In distribution |
| CC13A06N-45 | Needle Length 13mm | 12 | In distribution |
| CC11A06N-45 | Thread Diameter 0.07mm | 12 | In distribution |
| E19A04N-45 | Needle Length 19mm | 12 | In distribution |
| BP13A05N-45 | Needle Length 13mm | 12 | In distribution |
| BP11A06N-45 | Needle Length 11mm | 12 | In distribution |
| SP13A05H-45 | Thread Diameter 0.1mm | 12 | In distribution |
| SP17A05N-45 | Needle Length 17mm | 12 | In distribution |
| BP13A07N-45 | Needle Length 13mm | 12 | In distribution |
| BP11A05N-45 | Needle Length 11mm | 12 | In distribution |
| BP13A04N-45 | Thread Diameter 0.15mm | 12 | In distribution |
| CC13A04N-45 | Thread Diameter 0.15mm | 12 | In distribution |
| E19A06N-45 | Needle Length 19mm | 12 | In distribution |
| SP27A02N-45 | Needle Length 27mm | 12 | In distribution |
| E19A05N-45 | Thread Diameter 0.1mm | 12 | In distribution |
| E17A06N-45 | Needle Length 17mm | 12 | In distribution |
| SP19A04N-45 | Needle Length 19mm | 12 | In distribution |
| SP13A05N-45 | Needle Length 13mm | 12 | In distribution |
| E15A04N-45 | Needle Length 15mm | 12 | In distribution |
| E11A06N-45 | Needle Length 11mm | 12 | In distribution |
| SP15A04N-45 | Thread Diameter 0.15mm | 12 | In distribution |
| SP15A04H-45 | Needle Length 15mm | 12 | In distribution |
| BP13A06N-45 | Thread Diameter 0.07mm | 12 | In distribution |
| E15A04L-45 | Thread Diameter 0.15mm | 12 | In distribution |
| E13A06N-25 | Needle Length 13mm | 12 | In distribution |
| CC17A05N-45 | Needle Length 17mm | 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 |
|---|---|
| K042367 | 2004-10-14 |
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.