XOXO - Spectacle Frame, Size 52-16-135 - MCGEE GROUP, INC., THE

Duns Number:847029543

Device Description: Spectacle Frame, Size 52-16-135

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More Product Details

Catalog Number

XOSIENWINE052S16

Brand Name

XOXO

Version/Model Number

XO Siena Wine

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

HQR

Product Code Name

Apparatus, cautery, radiofrequency, ac-powered

Device Record Status

Public Device Record Key

6e772530-d82f-4f03-abae-c365bf7b1402

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