DIACOR, INC.

Address:2550 DECKER LAKE BLVD.,West Valley City,UT,84119,US

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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

Device, Patient Transfer, Powered (FRZ) (10)

Premarket Exempt

No Yes

Clear

Zephyr Patient Positioning and Transfer System - B237ZBL90 Catalog Number :

Device Description : Zephyr Blower Kit for 220v for ZTG-4 stretcher

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZBL9MR0 Catalog Number :

Device Description : Zephyr Blower Kit for 220v for ZTG-2 stretcher

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEP30 Catalog Number :

Device Description : Zephyr HDR Hover Board

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEP40 Catalog Number :

Device Description : Zephyr HDR Hover Board

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAAS010 Catalog Number :

Device Description : Zephyr HDR Accessory - Arcoma Table Kit. Includes end stop and extended guide r Zephyr HDR Accessory - Arcoma Table Kit. Includes end stop and extended guide rails for use with Arcoma Imaging Table and BodyTom Mobile CT

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAPS010 Catalog Number :

Device Description : Zephyr Accessory, Patient Stirrups with rail clamps

Device Class : 2

Duns Number: 605813559

Premarket Exempt : Yes

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPARC500 Catalog Number :

Device Description : Zephyr HDR Accessory - Rail Clamp

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPATS010 Catalog Number :

Device Description : Zephyr HDR Accessory - Trumpf Table Kit

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPATS020 Catalog Number :

Device Description : Zephyr HDR Accessory - Trumpf Table Kit End Stop, radiolucent version

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

Zephyr Patient Positioning and Transfer System - B237ZEPAUB500 Catalog Number :

Device Description : Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp - 2 scr Zephyr HDR Accessory -Universal Clamp Bracket for ELEKTA Universal Clamp - 2 screw mount design

Device Class : 2

Duns Number: 605813559

Premarket Exempt : No

Product Code : FRZ

Prescription Use : Yes

Device Count : 1

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