Blackbriar Regulatory Services, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (3)

Premarket Exempt

Clear

BRS Level 1 Procedure Face Mask with Ear Loops - 00850021617004 Catalog Number :

Device Description : Level 1 Procedure Face Mask with Ear Loops - Updated

Device Class : 2

Duns Number: 117425172

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

BRS Level 2 Procedure Mask with Ear Loops - 00850021617196 Catalog Number : BRS2189

Device Description : Level 2 Procedure Face Mask with Ear Loops

Device Class : 2

Duns Number: 117425172

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

BRS Level 3 Procedure Face Mask - 3 Layers - 00850021617561 Catalog Number : BRS3561

Device Description : Level 3 Procedure Face Mask with Ear Loops - 3 Layers

Device Class : 2

Duns Number: 117425172

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

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