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) (6) Laparoscope, General & Plastic Surgery (GCJ) (4)

Premarket Exempt

No Yes

Clear

FLEX - 00850190004483 Catalog Number :

Device Description : FENESTRATED GRASPER

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004490 Catalog Number :

Device Description : MONOPOLAR NEEDLE KNIFE

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004506 Catalog Number :

Device Description : MONOPOLAR SPATULA

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004513 Catalog Number :

Device Description : Flex Case Kit- Option 7

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

FLEX - 00850190004520 Catalog Number :

Device Description : Flex Case Kit- Option 8

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

FLEX - 00850190004537 Catalog Number :

Device Description : Flex Case Kit - Option 9

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

FLEX - 00850190004544 Catalog Number :

Device Description : Flex Case Kit- Option 10

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

FLEX - 00850190004551 Catalog Number :

Device Description : Flex Case Kit - Option 11

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

FLEX - 00850190004568 Catalog Number :

Device Description : Flex Case Kit - Option 12

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

Flex - 00850190004636 Catalog Number :

Device Description : Micro Flex Scissors

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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