Henry Schein - HSI Earloop Mask Level 1 - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: HSI Earloop Mask Level 1

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More Product Details

Catalog Number

5700739

Brand Name

Henry Schein

Version/Model Number

5700739

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)

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

65aa9dbb-ef6f-4563-9d8a-91ed4efd8043

Public Version Date

March 08, 2021

Public Version Number

4

DI Record Publish Date

October 30, 2019

Additional Identifiers

Package DI Number

20304040117198

Quantity per Package

6

Contains DI Package

10304040117191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34