2 catalogue numbers from 1272.SD125-00, listed by Peregrine Surgical, LLC., United States, under Cannula, Ophthalmic. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for 25GA Soft Tip Cannula – 1mm Silicone | Listed by | Peregrine Surgical, LLC., United States |
| FDA product code | HMX |
| Device type | Cannula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-10 |
| Record revised | 2024-09-11 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| Sizes | Needle gauge 25 G |
| UDI direct marking | Exempt |
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.