Paneffort, LLC

Address:700 Elmridge Center Drive,Rochester,NY,14626,US

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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

Non-Surgical Isolation Gown (OEA) (2) Shield, Protective, Personnel (KPY) (1)

Premarket Exempt

No Yes

Clear

Paneffort - 10810101310062 Catalog Number :

Device Description : AAMI Level 2 Isolation Gown. Full Back, Elastic Wrist, Blue. Regular/Large.

Device Class :

Duns Number: 018250858

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

Paneffort - 10810101310079 Catalog Number :

Device Description : AAMI Level 2 Isolation Gown. Full Back, Elastic Wrist, Blue. X-Large.

Device Class :

Duns Number: 018250858

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 10

Paneffort - 10810101310482 Catalog Number :

Device Description : Disposable Anti-Fog Face Shield. Full Length, Foam Head Protection, Elastic Head Disposable Anti-Fog Face Shield. Full Length, Foam Head Protection, Elastic Head Band. Regular/Large

Device Class :

Duns Number: 018250858

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 50

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