Safco Coverdent™ Mask - Mask blue ASTM level 1 - SAFCO DENTAL SUPPLY CO.

Duns Number:020417380

Device Description: Mask blue ASTM level 1

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More Product Details

Catalog Number

102-9815

Brand Name

Safco Coverdent™ Mask

Version/Model Number

102-9815

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"

-

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

a8bfbd86-a38d-41e9-aae5-984814293a83

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

August 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFCO 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 600
2 A medical device with a moderate to high risk that requires special controls. 23