MEDROBOTICS CORPORATION

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) (8) Colonoscope And Accessories, Flexible/Rigid (FDF) (1) Retractor, Ent (KAL) (1)

Premarket Exempt

No Yes

Clear

FLEX - 00850190004018 Catalog Number :

Device Description : FLEX BASE

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004025 Catalog Number :

Device Description : FLEX CART

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004032 Catalog Number :

Device Description : FLEX CONSOLE

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004049 Catalog Number :

Device Description : Flex TO Drive

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004063 Catalog Number :

Device Description : FLEX RETRACTOR SYSTEM

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004070 Catalog Number :

Device Description : FLEX STAND

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004087 Catalog Number :

Device Description : Flex TO Instrument Support & Assembly

Device Class :

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004094 Catalog Number :

Device Description : FLEX THERMAL EXHAUST TUBE

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

Flex - 00850190004100 Catalog Number :

Device Description : Flex Rectoscope

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : FDF

Prescription Use : No

Device Count : 1

Flex - 00850190004117 Catalog Number :

Device Description : TA Drive

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

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