"Tracho-Foam® Double-Sided Adhesive Foam Disc, Large 2.63"" OD (Box of 30)"

Primary DI
00792293053107
Brand
"Tracho-Foam® Double-Sided Adhesive Foam Disc, Large 2.63"" OD (Box of 30)"
Company
UROCARE PRODUCTS, INC.
Model
5310
Catalog number
5310
Device description
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).
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZRCement, Stomal Appliance, Ostomy
KGXTape And Bandage, Adhesive
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZRCement, Stomal Appliance, OstomyGastroenterology, Urology1
KGXTape And Bandage, AdhesiveGeneral Hospital1
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293053107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293053107007922930531077922930531070792293053107

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy base plate, concaveA non-sterile device designed with a concave surface intended to be applied and adhered to peristomal skin to facilitate correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. The concavity of the device is used to improve peristomal skin contact typically when a stoma is sitting on top of a bulge. It is typically self-applied by the patient. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height0.13Inch
Lumen/Inner Diameter1Inch
Outer Diameter2.63Inch
Weight0.003Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dark, dry place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-621-6013CUST.SUPPORT@UROCARE.COM

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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