Catalog Number

511151-29A

Brand Name

SPROTTE®

Version/Model Number

511151-29A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

May 25, 2024

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

3b29cdab-8665-4e69-8524-8a9dc62dc9ad

Public Version Date

July 15, 2021

Public Version Number

1

DI Record Publish Date

July 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-