2 catalogue numbers from RH-7414-10, listed by Summit Medical LLC, United States, under Splint, Intranasal Septal. 3 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Doyle P/F Nasal Pack | Listed by | Summit Medical LLC, United States |
| FDA product code | LYA |
| Device type | Splint, Intranasal Septal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4780 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-17 |
| Record revised | 2021-08-23 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Shelf box of 10 |
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.