Duns Number:796986144
Device Description: ACCY KIT 355560 SCS EXTNSION PASSER 60CM
Catalog Number
-
Brand Name
N/A
Version/Model Number
355560
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
K000105
Product Code
GZB
Product Code Name
STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Public Device Record Key
1f7ee1e0-b5f4-4afb-8ac6-89fec2ee7682
Public Version Date
October 04, 2018
Public Version Number
1
DI Record Publish Date
September 03, 2018
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 |