N/A - REVERSE PULL FACE MASK LG - FLEXMEDICS

Duns Number:028853567

Device Description: REVERSE PULL FACE MASK LG

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

RPFMLG

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

Yes

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

K111169

Product Code Details

Product Code

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Device Record Status

Public Device Record Key

137c8527-379d-4ff8-90d9-dd230aa45b03

Public Version Date

June 03, 2020

Public Version Number

1

DI Record Publish Date

May 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXMEDICS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 923