Duns Number:025460908
Device Description: CATHETER,EXTERNAL,MALE,EXO,LTX,LG,35MM
Catalog Number
DYND12301
Brand Name
Medline
Version/Model Number
DYND12301
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
5b990c8c-b397-4491-b843-e5963da592e8
Public Version Date
January 07, 2021
Public Version Number
1
DI Record Publish Date
December 30, 2020
Package DI Number
40080196030898
Quantity per Package
25
Contains DI Package
10080196030897
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| 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 |