Catalog Number

RF634

Brand Name

Dimension® EXL™ Total Vitamin D

Version/Model Number

10706480

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162298,K162298

Product Code

MRG

Product Code Name

SYSTEM, TEST, VITAMIN D

Public Device Record Key

1547e6ae-2ce8-4a9f-b71a-6e9e4c118748

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

December 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-