ULINE Tie-Back Surgical Mask - Light blue polypropylene tie-back surgical mask - ULINE, INC.

Duns Number:039612668

Device Description: Light blue polypropylene tie-back surgical mask with adjustable aluminum nose piece.

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More Product Details

Catalog Number

S-19254

Brand Name

ULINE Tie-Back Surgical Mask

Version/Model Number

S-19254

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123787,K123787,K123787

Product Code Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

Public Device Record Key

5c8930d6-59b5-4f5d-8639-f5b94e4093f3

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

January 24, 2017

Additional Identifiers

Package DI Number

30851253007411

Quantity per Package

6

Contains DI Package

10851253007417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"ULINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 2