Catalog Number

-

Brand Name

Vectris™

Version/Model Number

977D260

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

P840001

Product Code

LGW

Product Code Name

Stimulator, spinal-cord, totally implanted for pain relief

Public Device Record Key

da03ce0d-df76-40a8-aec4-903237e7bb3d

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-