Hedy SoftMask - Procedure Mask - AMD Medicom Inc

Duns Number:256880576

Device Description: Procedure Mask

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More Product Details

Catalog Number

420LFG

Brand Name

Hedy SoftMask

Version/Model Number

420LFG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

3142700d-4cf6-46ee-a640-6b2764440df1

Public Version Date

July 16, 2020

Public Version Number

3

DI Record Publish Date

November 23, 2018

Additional Identifiers

Package DI Number

D903420LFG2

Quantity per Package

6

Contains DI Package

D903420LFG1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"AMD MEDICOM INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 2