Uro-Prep® Protective Skin Barrier Wipes (Box of 50) - PROTECTIVE, BARRIER, DRESSING, SKIN, PADS, WIPES, - UROCARE PRODUCTS, INC.

Duns Number:070637129

Device Description: PROTECTIVE, BARRIER, DRESSING, SKIN, PADS, WIPES, SACHETTE, URINE COLLECTION, OSTOMY, MALE

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More Product Details

Catalog Number

5500

Brand Name

Uro-Prep® Protective Skin Barrier Wipes (Box of 50)

Version/Model Number

5500

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"

-

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

EXE

Product Code Name

Protector, Ostomy

Device Record Status

Public Device Record Key

75567a13-2eae-435c-8c08-3ef721bfbe65

Public Version Date

June 10, 2022

Public Version Number

5

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