Catalog Number

-

Brand Name

LUMEX

Version/Model Number

12-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

KQW

Product Code Name

Goniometer, Nonpowered

Public Device Record Key

46dacadb-a7c1-4f5b-a494-847103b7c45f

Public Version Date

June 02, 2021

Public Version Number

2

DI Record Publish Date

September 09, 2020

Package DI Number

M36812100002

Quantity per Package

100

Contains DI Package

M3681210001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box