Robrady Inc

Robrady Inc

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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

Accessory, Surgical Apparel (LYU) (2) Apparatus, Air Handling, Enclosure (FZI) (1)

Premarket Exempt

Yes

Clear

EndoShield - 00860008240101 Catalog Number :

Device Class :

Duns Number: 064578649

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

Respiratory Shield - 00860008240118 Catalog Number :

Device Class :

Duns Number: 064578649

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

Portable Negative Pressure Vacuum - 00860008240125 Catalog Number :

Device Class : 2

Duns Number: 064578649

Premarket Exempt : Yes

Product Code : FZI

Prescription Use : No

Device Count : 1

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