Nevro - Senza II - NEVRO CORP.

Duns Number:926599155

Device Description: Senza II

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More Product Details

Catalog Number

NIPG2000

Brand Name

Nevro

Version/Model Number

NIPG2000

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P130022

Product Code Details

Product Code

LGW

Product Code Name

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Device Record Status

Public Device Record Key

86ad2784-e159-44b8-93be-41581e1d5c36

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEVRO CORP." Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 74