Duns Number:809784593
Device Description: Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Coudé Tip
Catalog Number
-
Brand Name
Cure Pocket XL™
Version/Model Number
M14XLC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2022
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GBM
Product Code Name
Catheter, Urethral
Public Device Record Key
cb2b91ba-095f-4a33-8c6f-b46beb2a7daa
Public Version Date
February 02, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20815947020790
Quantity per Package
10
Contains DI Package
10815947020793
Package Discontinue Date
February 01, 2022
Package Status
Not 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |