Catalog Number

-

Brand Name

The Spanner Temporary Prostatic Stent

Version/Model Number

The Spanner Stent Size 6

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

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

P060010

Product Code

NZC

Product Code Name

Stent, Urethral, Prostatic, Semi-Permanent

Public Device Record Key

9335bf49-108c-474c-acb2-895cb9942679

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-