Duns Number:948904735
Device Description: Single Spike Tumescent Set - Non-Sterile
Catalog Number
-
Brand Name
Custom Medical Specialties, Inc.
Version/Model Number
CMS-1211-NS
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
0958db6e-d7a8-425b-bd17-9c8126451ec6
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
December 07, 2016
Package DI Number
00815849022744
Quantity per Package
100
Contains DI Package
00815849020030
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 |