Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. N7202 model consists of a 7/0 Nylon suture of length 30cm…
Non absorbable Ophthalmic Suture Needle is an ophthalmic medical device which consists of Stainless Steel needle and Nylon suture. N7202 model consists of a 7/0 Nylon suture of length 30cm attached with two 230 microns SS needles having the needle length of 6.0mm in both the ends of suture. Angle of curvature of both the needles are 140° [3/8 Circle]. Point profile of both needles are Taper point.
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
Record
Regulatory record for Aurolon | Listed by | Aurolab, India |
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K024090 |
| Record published | 2020-06-20 |
| Record revised | 2021-02-05 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 2 to 40 °C |
| Packaging | Box of 12 |
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.
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.