Duns Number:025460908
Device Description: CATHETER,EXTERNAL,MALE,EXO,LTX,SM,25MM
Catalog Number
DYND12303
Brand Name
Medline
Version/Model Number
DYND12303
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
234d9afa-fcc4-4d36-8f9e-0a8af93c8ec2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 14, 2016
Package DI Number
40080196030928
Quantity per Package
25
Contains DI Package
10080196030927
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |