Duns Number:070637129
Device Description: STRAP, URINE COLLECTION, LATEX, BUTTONS, REUSABLE, REPLACEMENT, SET OF 3Replacement Latex STRAP, URINE COLLECTION, LATEX, BUTTONS, REUSABLE, REPLACEMENT, SET OF 3Replacement Latex Leg Straps for use with all Urocare Latex Urine Collection Leg Bags and Male Urinal Systems.
Catalog Number
6006
Brand Name
Urocare® Latex Leg Straps with Buttons (Set of 3)
Version/Model Number
6006
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
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
FAQ
Product Code Name
Bag, Urine Collection, Leg, For External Use, Sterile
Public Device Record Key
6f434296-ba22-40f4-9a60-392d133a5b3a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 11, 2018
Package DI Number
10792293060065
Quantity per Package
10
Contains DI Package
00792293060068
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |