Duns Number:025460908
Device Description: TRAY,CATHETER,URETHRAL,RED-RUBBER,15FR
Catalog Number
DYNCX1816
Brand Name
Medline
Version/Model Number
DYNCX1816
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"
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
FCM
Product Code Name
Tray, catheterization, sterile urethral, with or without catheter (kit)
Public Device Record Key
f5d772e3-68db-469c-b3ef-50642bb3571f
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
40888277331632
Quantity per Package
20
Contains DI Package
10888277331631
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 |