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 - 00817355020405 Catalog Number :

Device Description : Green U-Max™ WideFace Extended Head Mask 42% perforation 3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020412 Catalog Number :

Device Description : Green ProfileFrame™ Extended Head Mask 42% perforation 3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020429 Catalog Number :

Device Description : Green ProfileFrame™ Extended Head Mask AccuPerf™ 3.2mm

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020436 Catalog Number :

Device Description : White Stereotactic Head Frame Mask SetType A

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020443 Catalog Number :

Device Description : White Stereotactic Head Frame Mask SetType B

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020450 Catalog Number :

Device Description : White Stereotactic Head & Shoulder Frame Mask SetType B

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020467 Catalog Number :

Device Description : Green Stereotactic Head Frame Mask SetType B

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Klarity Medical - 00817355020474 Catalog Number :

Device Description : Klarity Green Head Mask for BOS, 2.0mm 15% Perforation, Medium (31cm wide) Compa Klarity Green Head Mask for BOS, 2.0mm 15% Perforation, Medium (31cm 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 - 00817355020481 Catalog Number :

Device Description : Klarity Green Head Mask for BOS, 2.4mm 36% Perforation, Small (26cm Wide) Compat Klarity Green Head Mask for BOS, 2.4mm 36% Perforation, Small (26cm 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 - 00817355020498 Catalog Number :

Device Description : Klarity Green Head Mask for BOS, 2.4mm 36% Perforation, Medium (31cm wide) Compa Klarity Green Head Mask for BOS, 2.4mm 36% Perforation, Medium (31cm wide) Compatible with Qfix BOS Baseplates

Device Class : 2

Duns Number: 034824691

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

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