AXIOBIONICS

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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

Electrode, Cutaneous (GXY) (9) Media, Electroconductive (GYB) (1)

Premarket Exempt

No Yes

Clear

BioGel Velcro Electrode - B367127P20 Catalog Number : 127P

Device Description : Cutaneous Electrode Pair 1.5" x 5"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367128P20 Catalog Number : 128P

Device Description : Cutaneous Electrode Pair 1.5" x 6"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367130P20 Catalog Number : 130P

Device Description : Cutaneous Electrode Pair 1" x 1.5"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367133P20 Catalog Number : 133P

Device Description : Cutaneous Electrode Pair 3” x 5”

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367134P20 Catalog Number : 134P

Device Description : Cutaneous Electrode Pair 3.5" x 3.5"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367135P20 Catalog Number : 135P

Device Description : Cutaneous Electrode Pair 4" x 4"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367136P20 Catalog Number : 136P

Device Description : Cutaneous Electrode Pair 4" x 6"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Spectra 360 Electrode Gel - B367145M00 Catalog Number : 145M

Device Description : Electrode Gel Monthly Supply (4 8 oz tubes)

Device Class : 2

Duns Number: 033139835

Premarket Exempt : Yes

Product Code : GYB

Prescription Use : Yes

Device Count : 1

UE BioSleeve - B3673010 Catalog Number : 30

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

UE BioSleeve - B3673140 Catalog Number : 31

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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