Life Is Good - Magnifying Spectacle 51-20-140 (3.00) - MCGEE GROUP, INC., THE

Duns Number:847029543

Device Description: Magnifying Spectacle 51-20-140 (3.00)

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More Product Details

Catalog Number

LGKANEMTTR300

Brand Name

Life Is Good

Version/Model Number

LG Kane Matte Tort

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HOI

Product Code Name

Spectacle, magnifying

Device Record Status

Public Device Record Key

882a1a60-a7af-4e76-9841-aeb11f200e21

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MCGEE GROUP, INC., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 232
2 A medical device with a moderate to high risk that requires special controls. 1353