Medichoice - Mask Surgical PRIMAGARD80 Anti-Fog Film With Tie - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Mask Surgical PRIMAGARD80 Anti-Fog Film With Tie Aluminum Nose Piece Green Not Made With N Mask Surgical PRIMAGARD80 Anti-Fog Film With Tie Aluminum Nose Piece Green Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

Medichoice

Version/Model Number

PG4-4241

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

b19cdab9-41c1-4319-bea8-9ae174c2d948

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

August 20, 2016

Additional Identifiers

Package DI Number

50885632100718

Quantity per Package

6

Contains DI Package

10885632100710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1