Klarity Medical Products, LLC

Address:600 Industrial Pkwy,Heath,OH,43056,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

Accelerator, Linear, Medical (IYE) (10)

Premarket Exempt

No Yes

Clear

Klarity Medical - 00817355020511 Catalog Number :

Device Description : Klarity Green Head Mask for BOS, 2.4mm, 36% Perforation, Large (38cm wide) Compa Klarity Green Head Mask for BOS, 2.4mm, 36% Perforation, Large (38cm wide) Compatible with Qfix BOS Baseplates

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020528 Catalog Number :

Device Description : Klarity Green Head & Shoulder Mask for BOS, 2.4mm 36% Perforation, Large (48cm W Klarity Green Head & Shoulder Mask for BOS, 2.4mm 36% Perforation, Large (48cm Wide) Compatible with Qfix BOS Baseplates

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020535 Catalog Number :

Device Description : Green Small BoS Head Mask42% perforation3.2mm26cm wide

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020542 Catalog Number :

Device Description : Green Medium BoS Head Mask with Flap42% perforation3.2mm31cm wide

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020559 Catalog Number :

Device Description : Green Medium BoS Head Mask42% perforation3.2mm31cm wide

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020566 Catalog Number :

Device Description : Klarity Green Head Mask for BOS, 3.2mm, 42% Perforation, Large (38cm wide) Compa Klarity Green Head Mask for BOS, 3.2mm, 42% Perforation, Large (38cm wide) Compatible with Qfix BOS Baseplates

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020573 Catalog Number :

Device Description : Green Large BoS Head & Shoulder Mask42% perforation3.2mm48cm wide

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020580 Catalog Number :

Device Description : Light Green O-Type 5-Point Head & Shoulder Mask (with nosehole) 12% perforation2.4mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020597 Catalog Number :

Device Description : Klarity Green O-Type Head and Shoulder Mask 3.2mm, 42% Perforation, 5 Point, Wit Klarity Green O-Type Head and Shoulder Mask 3.2mm, 42% Perforation, 5 Point, With Nose Hole, for Klarity and Orfit Baseplates

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020603 Catalog Number :

Device Description : Green O-Type 5-Point Head & Shoulder Mask (with nosehole) AccuPerf™ 3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

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