Catalog Number

PTRC3000

Brand Name

Omnia

Version/Model Number

PTRC3000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

P130022

Product Code

LGW

Product Code Name

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Public Device Record Key

9378c8f0-4aea-44b3-8641-62974d0ba126

Public Version Date

April 19, 2022

Public Version Number

1

DI Record Publish Date

April 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-