DEROYAL INDUSTRIES, INC.

DEROYAL INDUSTRIES, INC.

Address:200 DEBUSK LN.,POWELL,TN,37849,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

Orthosis, cervical (IQK) (5) Restraint, protective (FMQ) (2) SPLINT, HAND, AND COMPONENTS (ILH) (2) SLING, ARM (ILI) (1)

Premarket Exempt

No Yes

Clear

DeRoyal - 00749756000017 Catalog Number : M2011D-U

Device Description : Limb Holder, Wrist/Ankle

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : FMQ

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000048 Catalog Number : M2031

Device Description : Limb Holder, Wrist/Ankle

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : FMQ

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000086 Catalog Number : 1000159

Device Description : ELASTIC SHOULDER IMMOBILIZER

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : ILI

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000109 Catalog Number : 1000251

Device Description : Cervical Collar

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : IQK

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000123 Catalog Number : 1000275

Device Description : WRIST SPLINT RIGHT OR LEFT

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000130 Catalog Number : 1000285

Device Description : WRIST AND FOREARM

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : ILH

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000147 Catalog Number : 1000301

Device Description : Cervical Collar

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : IQK

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000161 Catalog Number : 1000351

Device Description : Cervical Collar

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : IQK

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000185 Catalog Number : 1000401

Device Description : Cervical Collar

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : IQK

Prescription Use : Yes

Device Count : 1

DeRoyal - 00749756000253 Catalog Number : 1001-01

Device Description : CERVICAL COLLAR

Device Class : 1

Duns Number: 096372255

Premarket Exempt : Yes

Product Code : IQK

Prescription Use : Yes

Device Count : 1

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