Freedom-8A Receiver Kit Channel A US w/ Receiver - Freedom Spinal Cord Stimulator System Freedom-8A - STIMWAVE TECHNOLOGIES INCORPORATED

Duns Number:078294927

Device Description: Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel A US w/ Receiver

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More Product Details

Catalog Number

-

Brand Name

Freedom-8A Receiver Kit Channel A US w/ Receiver

Version/Model Number

FR8A-RCV-A0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K170141

Product Code Details

Product Code

GZB

Product Code Name

Stimulator, Spinal-Cord, Implanted (Pain Relief)

Device Record Status

Public Device Record Key

cfd74265-cac2-4863-9049-89799823b91f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STIMWAVE TECHNOLOGIES INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58