Tracho-Foam® Double-Sided Adhesive Foam Disc, Large 2.63" OD (Box of 30) - DISC, WAFER, DRESSING, ADHESIVE, FOAM, OSTOMY, - UROCARE PRODUCTS, INC.

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).

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More Product Details

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

Product Characteristics

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 Details

Product Code

EZR

Product Code Name

Cement, Stomal Appliance, Ostomy

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UROCARE PRODUCTS, INC." Characteristics
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