BIO PROTECH USA, INC.

Address:13620 Benson Ave,Chino,CA,91710,US

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (6) Electrode, Cutaneous (GXY) (4)

Premarket Exempt

No Yes

Clear

Bio Protech - 00817120020241 Catalog Number :

Device Description : Pro-Pencil SBH: SBH- Slim, Hand Control, Button Switch, General Blade, with Hols Pro-Pencil SBH: SBH- Slim, Hand Control, Button Switch, General Blade, with Holster, Sterile, 1pcs/per pouch

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020258 Catalog Number :

Device Description : Pro-Pencil:SBNH- SBNH, Hand Control, Button Switch, Non-Stick, With Holster, Ste Pro-Pencil:SBNH- SBNH, Hand Control, Button Switch, Non-Stick, With Holster, Sterile, 1/pc per pouch

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020265 Catalog Number :

Device Description : Pro-Pencil: SRH-SRH: Slim, Hand Control, Rock Switch, General Blade, with Holste Pro-Pencil: SRH-SRH: Slim, Hand Control, Rock Switch, General Blade, with Holster, Sterile, 1pc/per pouch

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020272 Catalog Number :

Device Description : Pro-Pencil: SRNH-SRNH, Hand Control, Rocker Switch, Slim Type, Non-Stick, With H Pro-Pencil: SRNH-SRNH, Hand Control, Rocker Switch, Slim Type, Non-Stick, With Holster, Sterile, 1/pc pouch

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020289 Catalog Number :

Device Description : 9551F- Grounding Pads, Dispersive Electrode, Adult, Foam, Non-Corded, Single Pad 9551F- Grounding Pads, Dispersive Electrode, Adult, Foam, Non-Corded, Single Pad, Horizontal (5 pcs/pouch, 40 pouches in Master Case) DO NOT USE

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020296 Catalog Number :

Device Description : 9552F- Non-Corded Grounding Pads, Adult, Foam, Dual, Horizontal Pad (5 pcs/pouch 9552F- Non-Corded Grounding Pads, Adult, Foam, Dual, Horizontal Pad (5 pcs/pouch, 40 pouches in Master Case) (Do Not Use)

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020302 Catalog Number :

Device Description : 30RdWCBZ(NST) - 30mm Round, White Fabric, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020319 Catalog Number :

Device Description : 4848BCAZ(BLUE)- 48mmx48mm Square, Blue Fabric, Carbon, Blue Gel, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020326 Catalog Number :

Device Description : 4848FCBZGN(NST)- 48mmx48mm Square Electrode, Foam, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020333 Catalog Number :

Device Description : 4848WCBZ(NST/ECO)- Econotens, 30mil gel, 48x48mm Square Electrode, White Fabric, 4848WCBZ(NST/ECO)- Econotens, 30mil gel, 48x48mm Square Electrode, White Fabric, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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