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

Cane (IPS) (8) Walker, Mechanical (ITJ) (2)

Premarket Exempt

No Yes

Clear

Round Handle Cane with Vinyl Grip - 00616784013114 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

Round Handle Cane with Foam Grip - 00616784013213 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

Offset Cane - 00616784013312 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

Bariatric Offset Cane - 00616784013411 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

T-Handle Folding Cane - 00616784013510 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

Quad Cane - Small Base - 00616784013619 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

Quad Cane - Large Base - 00616784013718 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

Bariatric Quad Cane - Large Base - 00616784013817 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : IPS

Prescription Use : No

Device Count : 1

Adult Two Button Folding Walker - 00616784016016 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Junior Two Button Folding Walker - 00616784016115 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

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