Catalog Number

1166-4K150

Brand Name

Tuohy NRFit

Version/Model Number

1166-4K150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 15, 2025

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"

Yes

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

K160297,K160297

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

ea4f53fa-a1a3-4145-a4fd-b3d6fb83ae8a

Public Version Date

March 16, 2021

Public Version Number

2

DI Record Publish Date

September 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-