Catalog Number

001163-38F

Brand Name

Spinal Manometer NRFit

Version/Model Number

001163-38F

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

K170305,K170305

Product Code

FMJ

Product Code Name

MANOMETER, SPINAL-FLUID

Public Device Record Key

e3058481-f32a-41fc-b8ac-9a9e81cc28f0

Public Version Date

March 12, 2021

Public Version Number

2

DI Record Publish Date

July 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-