BOXOUT, LLC

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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

Device, Iontophoresis, Other Uses (EGJ) (4) Electrode, Cutaneous (GXY) (4) Oximeter, Infrared, Sporting, Aviation (OCH) (1) Pad, Heating, Powered (IRT) (1)

Premarket Exempt

Yes No

Clear

BODYMED - 00815991021695 Catalog Number :

Device Description : CARBON ELECTRODE, 3" BY 4.75" RECTANGULAR. 1PC/BAG

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BodyMed - 00815991022050 Catalog Number : ZZAI275

Device Description : BODYMED IONTOPHORESIS, ELECTRODE SMALL 2.75" X 2.75", 12/BOX

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991022067 Catalog Number : ZZAI325

Device Description : BODYMED IONTOPHORESIS, ELECTRODES MEDIUM 3.25" X 3.25", 12/BOX

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991022074 Catalog Number : ZZAI35

Device Description : BODYMED IONTOPHORESIS, ELECTRODES LARGE, 3.5" X 3.5", 12/BOX

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

BodyMed - 00815991022081 Catalog Number : ZZAI375B

Device Description : BODYMED IONTOPHORESIS, ELECTRODES BUTTERFLY 3.75" X 3.75", 12/BOX

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : EGJ

Prescription Use : Yes

Device Count : 1

Reserv - 00815991022098 Catalog Number : RSV2X4U10

Device Description : RESERV TENS ELECTRODE, 2" X 4" rectangle, 4 pads/pack, 10 packs/bag, 40 bags/case

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Reserv - 00815991022104 Catalog Number : RSV2IRU10

Device Description : RESERV TENS ELECTRODE, 2" round, . 4 pads/pack, 10 packs/bag, 50 bags/case

Device Class :

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BodyMed - 00815991022623 Catalog Number : ZZHPS1623

Device Class : 2

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

BodyMed - 00815991022630 Catalog Number : BDMOXMTRBLK

Device Class : 2

Duns Number: 066689993

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

BodyMed - 00815991022838 Catalog Number : NPP22TAB

Device Description : BODYMED SELF-ADHERING ELECTRODES, FABRIC BACK, REUSABLE, 2" X 2" SQUARE, WITH PULL TAB

Device Class : 2

Duns Number: 066689993

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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