HAYS, INC.

Address:5432 W CENTRAL AVE STE B,Ottawa Hills,OH,43615,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

Drape, Surgical (KKX) (5) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

Hays Inc. - 00860003700822 Catalog Number : HS1500AS

Device Description : Hays Innovations Anchor Sound Device

Device Class :

Duns Number: 079906040

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Hays Inc - 00860003700853 Catalog Number : HS2100SS

Device Description : Hays Innovations Sterile Short US Probe Cover Kit

Device Class :

Duns Number: 079906040

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

Hays Innovations - 00869566000202 Catalog Number : E632203NEO-01N

Device Description : Regular PE Film Probe Cover 6" X 48"

Device Class :

Duns Number: 079906040

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Hays Innovations - 00869566000233 Catalog Number : H1000SE

Device Description : Hays Ultrasound kit

Device Class : 2

Duns Number: 079906040

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Hays Innovations - 00869566000240 Catalog Number : H1000S

Device Description : Hays Ultrasound kit

Device Class : 2

Duns Number: 079906040

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Hays Inc - 00869566000271 Catalog Number : HS2000HL

Device Description : Hays Innovations Sterile Ultrasound Probe Cover Kit

Device Class :

Duns Number: 079906040

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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