Duns Number:796986144
Device Description: LEAD 387445 OCTAD 1X8 TEST STIM eMAN US
Catalog Number
-
Brand Name
NA
Version/Model Number
387445
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"
-
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
K051773
Product Code
GZB
Product Code Name
STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Public Device Record Key
3615a802-8c4a-40fd-a9d0-8f9ed7b73777
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 08, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |