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

Laparoscope, General & Plastic Surgery (GCJ) (7) Retractor, Ent (KAL) (2) Nasopharyngoscope (Flexible Or Rigid) (EOB) (1)

Premarket Exempt

No Yes

Clear

Flex - 00850190004643 Catalog Number :

Device Description : Micro Flex Sickle Knife

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Flex - 00850190004650 Catalog Number :

Device Description : Micro Flex Alligator Grasper

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Flex - 00850190004667 Catalog Number :

Device Description : Micro Flex Triangle Forceps

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Flex - 00850190004674 Catalog Number :

Device Description : Needle Driver

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Flex - 00850190004681 Catalog Number :

Device Description : Micro Flex Laser Holder 1100

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Flex - 00850190004698 Catalog Number :

Device Description : Hypercurved Laryngeal Blade, 120-150mm x 36mm Wide

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

Flex - 00850190004704 Catalog Number :

Device Description : Hypercurved Laryngeal Blade, 92-125mm x 36mm Wide

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004711 Catalog Number :

Device Description : Flex TA Instrument Support & Assembly

Device Class :

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

Flex - 00850190004728 Catalog Number :

Device Description : Bipolar Maryland Dissector

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004735 Catalog Number :

Device Description : Monopolar L-Hook

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

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