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) (10)

Premarket Exempt

No Yes

Clear

UE BioSleeve - B3673240 Catalog Number : 32

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 - B3673340 Catalog Number : 33

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 - B3673350 Catalog Number : 33

Device Description : Cutaneous Electrode GarmentReleased as revision 5 on 2017-11-28

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

UE BioSleeve - B3673440 Catalog Number : 34

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 - B3673500 Catalog Number : 35

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 - B367360 Catalog Number : 36

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 - B3673600 Catalog Number : 36

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioBrief - B3676000 Catalog Number : 60

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioShorts - B3676100 Catalog Number : 61

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioShortX - B3676210 Catalog Number : 62

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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