BENCO - MASK BENCO LVL 2 BLU BX50 - BENCO DENTAL SUPPLY CO.

Duns Number:015108087

Device Description: MASK BENCO LVL 2 BLU BX50

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More Product Details

Catalog Number

5251-470

Brand Name

BENCO

Version/Model Number

5251-470

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

6163f82a-ca95-44fb-800a-91333934321b

Public Version Date

March 08, 2021

Public Version Number

5

DI Record Publish Date

January 31, 2018

Additional Identifiers

Package DI Number

10366975013023

Quantity per Package

10

Contains DI Package

00366975013026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BENCO DENTAL SUPPLY CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1364
2 A medical device with a moderate to high risk that requires special controls. 377
U Unclassified 15