Duns Number:796986144
Device Description: LEAD 977A290 VECTRIS MRICS SUBCOMPACT
Catalog Number
-
Brand Name
Vectris™ SureScan®
Version/Model Number
977A290
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P840001
Product Code
LGW
Product Code Name
Stimulator, spinal-cord, totally implanted for pain relief
Public Device Record Key
e37e51b3-86fb-412f-bf70-6bf8ea901df7
Public Version Date
March 07, 2022
Public Version Number
1
DI Record Publish Date
February 26, 2022
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 |