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

Retractor, Ent (KAL) (10)

Premarket Exempt

No Yes

Clear

FLEX - 00850190004285 Catalog Number :

Device Description : UPPER GUARD, BROAD

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004292 Catalog Number :

Device Description : UPPER GUARD, NARROW

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004308 Catalog Number :

Device Description : TONGUE BLADE, 50-80MM X 32MM WIDE

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004315 Catalog Number :

Device Description : TONGUE BLADE, 50-80MM X 38MM WIDE

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004322 Catalog Number :

Device Description : TONGUE BLADE, 50-80MM X 40MM WIDE-LEFT EXPOSURE

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004339 Catalog Number :

Device Description : TONQUE BLADE, 50-80mm X 40mm WIDE-RIGHT EXPOSURE

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004346 Catalog Number :

Device Description : TONGUE BLADE, 80-110MM X 32MM WIDE

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004353 Catalog Number :

Device Description : LARYNGEAL BLADE, 90-120MM X 32MM WIDE

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004360 Catalog Number :

Device Description : LARYNGEAL BLADE, 90-120MM X 36MM WIDE

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004377 Catalog Number :

Device Description : TONGUE BLADE, TEXTURED, 80-110mm X 40mm Wide, Left Exposure, Radius 130mm

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

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