Catalog Number
CHCB1000
Brand Name
Senza®
Version/Model Number
CHCB1000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
For Single-Use
-
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
P130022
Product Code
LGW
Product Code Name
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Public Device Record Key
d69754a6-b082-49ed-863e-bc5aa495e68d
Public Version Date
October 16, 2019
Public Version Number
1
DI Record Publish Date
October 08, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 74 |