DYNAREX CORPORATION

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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

Crutch (IPR) (8) Cane (IPS) (1) Curette, Ear (JYG) (1)

Premarket Exempt

No Yes

Clear

Disposable Ear Specula Tips - 00061678471172 Catalog Number :

Device Description : Disposable Ear Specula Tips, 4.25mm

Device Class :

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : JYG

Prescription Use : No

Device Count : 850

Aluminum Crutches - Child - 00616784010014 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Aluminum Crutches - Youth - 00616784010113 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Aluminum Crutches - Adult - 00616784010212 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Aluminum Crutches - Tall - 00616784010311 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Universal Crutches - 00616784010410 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Forearm Crutches - Youth - 00616784011011 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Forearm Crutches - Adult - 00616784011110 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Forearm Crutches - Tall - 00616784011219 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPR

Prescription Use : No

Device Count : 1

Round Crook Handle Cane with Tab Lock Silencer - 00616784013015 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

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