Duns Number:070637129
Device Description: SHEATH, MALE, EXTERNAL, CATHETER, LATEX, HIGH-QUALITY, DISPOSABLE, MEDIUM 30MM BOX of 100T SHEATH, MALE, EXTERNAL, CATHETER, LATEX, HIGH-QUALITY, DISPOSABLE, MEDIUM 30MM BOX of 100These latex sheaths are used in conjunction with Uro-Con® Catheter Inserts and pliable white-rubber tubing to construct Uro-Con® “Texas-Style” male external catheters
Catalog Number
500330
Brand Name
Uro-Con® "High-Quality" Latex Sheaths, Medium 30mm (Box of 100)
Version/Model Number
500330
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
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
NNX
Product Code Name
Device, Incontinence, Urosheath Type, Non-Sterile
Public Device Record Key
98ed4d3d-ad09-4eee-bd91-ff7c67583525
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 30, 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 |