Duns Number:070637129
Device Description: CLAMP, TUBE, URINE COLLECTION, ADJUSTABLE, REUSABLE, WHITEFeatures:6 Adjustable Positions CLAMP, TUBE, URINE COLLECTION, ADJUSTABLE, REUSABLE, WHITEFeatures:6 Adjustable Positions to control flow of urine. Maximum Tube Size O.D: 0.46"
Catalog Number
6999
Brand Name
Urocare® Thumb Tube Clamp, Adjustable
Version/Model Number
6999
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
-
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
4d05cc4a-0d66-4129-907c-60a601e3927c
Public Version Date
May 10, 2021
Public Version Number
8
DI Record Publish Date
April 11, 2018
Package DI Number
20792293069997
Quantity per Package
50
Contains DI Package
00792293069993
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 |