Duns Number:948904735
Device Description: Polyvinyl Urological Drainage Bag for Skytron Systems - Non-Sterile
Catalog Number
-
Brand Name
Custom Medical Specialties, Inc.
Version/Model Number
CMS-969P
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
47af004f-cab3-4959-a024-db2a7e86ba01
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 22, 2016
Package DI Number
00815849022713
Quantity per Package
20
Contains DI Package
00815849022706
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 | 78 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 72 |