Catalog Number

-

Brand Name

Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

Version/Model Number

500014

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151072,K151072,K151072

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

5b04139a-6b51-40a9-b15c-c52fdd65c9d7

Public Version Date

June 15, 2022

Public Version Number

2

DI Record Publish Date

September 20, 2018

Package DI Number

18500019130006

Quantity per Package

10

Contains DI Package

08500019130009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 10