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 - 00817355020009 Catalog Number :

Device Description : Klarity White Thermoplastic Sheet 11% perforation, 1.6mm, 610x460mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020016 Catalog Number :

Device Description : Green S-Type Head Mask AccuPerf™3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Klarity Medical - 00817355020023 Catalog Number :

Device Description : Green S-Type Extended Head MaskAccuPerf™3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Klarity Medical - 00817355020030 Catalog Number :

Device Description : Green S-Type Head Mask 42% perforation3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Klarity Medical - 00817355020047 Catalog Number : RG461CH

Device Description : Klarity Green Proton Therapy Head Mask, 3.2mm W/PINS

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020054 Catalog Number : RG461C

Device Description : Klarity Green Proton Therapy Head and Shoulder Mask, 3.2mm W/PINS

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020061 Catalog Number :

Device Description : Green S-Type Head & Shoulder Mask 42% perforation3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Klarity Medical - 00817355020078 Catalog Number :

Device Description : Green S-Type Head & Shoulder Pediatric Mask36% perforation2.4mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Klarity Medical - 00817355020085 Catalog Number :

Device Description : Green S-Type Head & Shoulder Pediatric Mask42% perforation3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Klarity Medical - 00817355020092 Catalog Number :

Device Description : Green S-Type Head & Shoulder Mask AccuPerf™2.4mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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