Acanthus
Acanthus Condom Catheter Medium-Large with 3ml Skin Adhesive
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Fesun Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| JM Medical Co., Ltd. | Liaocheng | Shandong | Contract manufacturer | 25 |
| Wuhan Sitaili Medical Apparatus Development Co., Ltd. | Wuhan | Hubei | Manufacturer | 12 |
Record
| Listed by | Acanthus Medical Creations, LLC, United States |
|---|---|
| FDA product code | NNY |
| Device type | Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-15 |
| Record revised | 2026-05-28 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Standard Room Temperature Conditions |
| Packaging | Case of 3, case of 6, case of 9, case of 15, case of 2, box of 30 |
| Sizes | Lumen/inner diameter 21.98 to 26.98 mm |
| Distribution end date | 2024-12-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACC019796 | Lumen/Inner Diameter 26.98 mm | In distribution |
| ACC019795 | Lumen/Inner Diameter 21.98 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 15 |
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.