Catalog Number

C-008.32.441

Brand Name

MPACK LL LED LOUPE LIGHT SET

Version/Model Number

C-008.32.441

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 04, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FSP

Product Code Name

LOUPE, DIAGNOSTIC/SURGICAL

Public Device Record Key

cd415629-b4ce-4c69-a4e1-0326bb51645b

Public Version Date

January 05, 2021

Public Version Number

2

DI Record Publish Date

September 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-