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) (9) Laparoscope, General & Plastic Surgery (GCJ) (1)

Premarket Exempt

No Yes

Clear

FLEX - 00850190004384 Catalog Number :

Device Description : TONGUE BLADE, TEXTURED, 80-110MM X 40MM WIDE, RIGHT EXPOSURE, RADIUS 130MM

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004391 Catalog Number :

Device Description : STRAIGHT LARYNGEAL BLADE, 85-115mm X 36mm Proximal X 23mm Distal

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004407 Catalog Number :

Device Description : FLEX STRAIGHT LARYNGEAL BLADE, 130-160mm X 36mm Proximal X 16mm Distal

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004414 Catalog Number :

Device Description : CURVED LARYNGEAL BLADE, 85-115mm X 36mm Proximal X 23mm Distal

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004421 Catalog Number :

Device Description : FLEX CURVED LARYNGEAL BLADE, 130-160mm X 36mm Proximal X 16mm Distal

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004438 Catalog Number :

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

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004445 Catalog Number :

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

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004452 Catalog Number :

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

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004469 Catalog Number :

Device Description : RETRACTOR BODY

Device Class : 1

Duns Number: 002764627

Premarket Exempt : Yes

Product Code : KAL

Prescription Use : Yes

Device Count : 1

FLEX - 00850190004476 Catalog Number :

Device Description : MONOPOLAR MARYLAND DISSECTOR

Device Class : 2

Duns Number: 002764627

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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