SAFEOP SURGICAL, INC.

SAFEOP SURGICAL, INC.

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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

Electromyograph, Diagnostic (IKN) (10) Stimulator, Electrical, Evoked Response (GWF) (10) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

Yes

Clear

EPAD - 00851641007008 Catalog Number : 100085

Device Description : Full EPAD System

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GXY, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007015 Catalog Number : 100032

Device Description : EPAD Control Box /Head Box

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007022 Catalog Number : 100059

Device Description : EPAD POWER SUPPLY

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007039 Catalog Number : 100086

Device Description : EPAD Tablet Staged

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007046 Catalog Number : 100087

Device Description : EPAD wireless charger for EPAD Tablet 100086

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007053 Catalog Number : 100389

Device Description : EPAD USB-A to MICRO USB-A Cable

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007060 Catalog Number : 100390

Device Description : EPAD USB OTG Cable

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007077 Catalog Number : 100024

Device Description : EPAD Acquisition white right long cable

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007084 Catalog Number : 100023

Device Description : Acquisition red left long cable

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

EPAD - 00851641007091 Catalog Number : 100022

Device Description : EPAD Stim yellow right long cable

Device Class : 2

Duns Number: 078641162

Premarket Exempt : Yes

Product Code : IKN, GWF

Prescription Use : Yes

Device Count : 1

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