Duns Number:070637129
Device Description: ADHESIVE REMOVER, PADS, WIPES, SACHETTE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL ADHESIVE REMOVER, PADS, WIPES, SACHETTE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Urocare® adhesive remover has been specifically formulated for dissolving and removing unwanted adhesive or adhesive residue from urinary and ostomy appliances, tens units, monitoring electrodes, skin and can even be used for the removal of tar. Packaged in a small, convenient wipe, Urocare® adhesive remover pads are the perfect solution to aid in the removal of adhesive residue left behind by male external catheters. They may be used to soften the adhesive of double-sided adhesive foam strips as well as most brush-on medical adhesives. They contain a lab tested, non-toxic, citrus-based solution that may also be used to remove these types of medical adhesives or adhesive residue from skin and appliances in preparation for the use of a new adhesive strip/wafer. It is recommended that a male external catheter be changed once a day to promote healthy skin. With the use of Urocare® adhesive remover pads, a male external catheter can be changed quickly and easily.Key Features:• NON-TOXIC—Lab Tested, non-toxic and free from harsh solvents.• Citrus-Based—Fresh citrus scent and biodegradable.• Many Uses—Use on nitro patches, tens units, electrodes, even tar.• Convenient—Travel size pads are small and easy to use• Soap & Water Clean-Up—Just wash, rinse and dry• Suitable for Hospital, Long-Term Care and Home Use• Alcohol-Free Formula• Environmentally Friendly—Does not contain ozone-depleting chloro-fluorocarbons• Convenient Packaging—Use only what you need so there's less wasteNote: For external use only.
Catalog Number
5600
Brand Name
Urocare® Adhesive Remover Pads (Box of 50)
Version/Model Number
5600
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"
-
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
45bbbb89-9244-4af1-8125-1fa0572542a7
Public Version Date
June 10, 2022
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 |