Catalog Number

5510

Brand Name

Algovita®

Version/Model Number

5510-USA

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

-

Product Code

LGW

Product Code Name

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Public Device Record Key

6a5ef8e5-d8ef-446e-9838-4f156e953d47

Public Version Date

August 23, 2019

Public Version Number

3

DI Record Publish Date

December 01, 2015

Package DI Number

10821329580434

Quantity per Package

5

Contains DI Package

00821329580437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box