Duns Number:070637129
Device Description: DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPE DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, STOMA, TRACHEOSTOMY, VOICE RESTORATION, SPEECH, VALVETracho-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).
Catalog Number
5310
Brand Name
Tracho-Foam® Double-Sided Adhesive Foam Disc, Large 2.63" OD (Box of 30)
Version/Model Number
5310
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZR
Product Code Name
Cement, Stomal Appliance, Ostomy
Public Device Record Key
6a6e7b2d-8cf8-4dad-8fef-7a209a308273
Public Version Date
January 22, 2021
Public Version Number
4
DI Record Publish Date
June 01, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 140 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |