DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPEECH, VALVE Tracho-Foam® adhesive foam discs are soft, pliable foam discs specifically designed for…
DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPEECH, VALVE Tracho-Foam® adhesive foam discs are soft, pliable foam discs specifically designed for the unique bonding applications of appliances to the skin and are suitable for securing valve housings of voice restoration systems to the body. With adhesive coated on both sides, they provide a comfortable, air-tight seal that conforms to the irregular contours of the stoma and eliminate hissing a side effect often found in other thinner or less flexible products. Key Features: • Ensolite Foam → Hypo-Allergenic • Closed-Cell Foam Structure → for an air-tight seal that eliminates hissing. • Soft and Pliable → Easily conforms to irregular contours of the body. • Perspiration resistant → It retains it’s adhesive qualities even when sweating. • Easy to apply and Remove → Just peel ‘n’ Stick to apply, peel back to remove. If the disc is difficult to remove, Urocare® Adhesive Remover Pads may be used to soften the adhesive and assist in the removal of the disc. They contain a non-toxic, citrus-based adhesive remover that may also be used to remove most types of medical adhesive or adhesive residue from skin and appliances or in preparation for use of a new disc. Most medical grade adhesive removers will work basically in the same manner; however, consult your doctor or speech therapist to decide the best product for you and how to use it safely. For more information → see Urocare® Adhesive Remover Pads (#5600). In the event of skin that has become sensitive to aggressive medical adhesives, Urocare® has developed Uro-Prep® a protective skin barrier wipe for used under all types of medical adhesives. They protect delicate, sensitive skin from aggressive adhesives often used in conjunction with urinary or ostomy appliances. Uro-Prep® wipes are safe, effective, and for external use only. For more information → see Uro-Prep® (#5500).
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (1), Hunan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Tracho-Foam® Double-Sided Adhesive Foam Disc, Standard 2.25″ OD (Box of 30) | Listed by | Urocare Products, Inc., United States |
| FDA product code | EZR |
| Device type | Cement, Stomal Appliance, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-01 |
| Record revised | 2022-11-09 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in cool, dark, dry place. |
| Sizes | Outer diameter 2.25 in; lumen/inner diameter 1 in; height 0.13 in; weight 0.002 lb |
| 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.