MEDROBOTICS CORPORATION

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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

Nasopharyngoscope (Flexible Or Rigid) (EOB) (4) Retractor, Ent (KAL) (4) Laparoscope, General & Plastic Surgery (GCJ) (2)

Premarket Exempt

Yes No

Clear

Flex - 00850190004124 Catalog Number :

Device Description : TA Instrument Support

Device Class :

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004131 Catalog Number :

Device Description : Support Arm & Clamp

Device Class : 2

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : EOB

Prescription Use : Yes

Device Count : 1

Flex - 00850190004155 Catalog Number :

Device Description : TO-LX Drive

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004162 Catalog Number :

Device Description : FLEX LASER HOLDER

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Flex - 00850190004193 Catalog Number :

Device Description : 3D Camera

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004209 Catalog Number :

Device Description : FLEX MONOPOLAR SCISSORS

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004247 Catalog Number :

Device Description : FRAME MOUNT

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004254 Catalog Number :

Device Description : FRAME

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004261 Catalog Number :

Device Description : CHEEK RETRACTOR

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004278 Catalog Number :

Device Description : TORQUE ADJUSTMENT TOOL

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

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