SpF®-PLUS-Mini (60 uA/M) - SPF-PLUS 60/M Implantable Spinal Fusion Stimulator - EBI, LLC

Duns Number:050410323

Device Description: SPF-PLUS 60/M Implantable Spinal Fusion Stimulator

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More Product Details

Catalog Number

10-1398M

Brand Name

SpF®-PLUS-Mini (60 uA/M)

Version/Model Number

10-1398M

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

P850035

Product Code Details

Product Code

LOE

Product Code Name

Stimulator, Invasive Bone Growth

Device Record Status

Public Device Record Key

409e3440-afc5-4742-8612-8f26be5e9b19

Public Version Date

March 10, 2022

Public Version Number

4

DI Record Publish Date

September 19, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EBI, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7
3 A medical device with high risk that requires premarket approval 70