Duns Number:948904735
Device Description: 12" Expandable Tube w/ 6mm Adapter Plug - Non-Sterile
Catalog Number
-
Brand Name
Custom Medical Specialties, Inc.
Version/Model Number
CMS-603
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
01a32773-0653-45f5-9b9a-72c75f591bf3
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 24, 2019
Package DI Number
00815849023314
Quantity per Package
50
Contains DI Package
00815849023307
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 |