Duns Number:796986144
Device Description: CABLE 355531 MULTI-LEAD TRIALING EMAN US
Catalog Number
-
Brand Name
NA
Version/Model Number
355531
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
K102523
Product Code
GZB
Product Code Name
STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Public Device Record Key
74bd0123-2794-4f23-8596-b3b803a19fdd
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 18, 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 |