ONKOS SURGICAL, INC.

Address:77 E HALSEY RD,Parsippany,NJ,07054,US

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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

TRAY, SURGICAL, INSTRUMENT (FSM) (10)

Premarket Exempt

No Yes

Clear

ELEOS™ - B27800103000110 Catalog Number : 001-03-00011

Device Description : ELEOS™ INSTRUMENTATION TRAY, PROXIMAL TIBIA TRIALS, TRAY 11

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000120 Catalog Number : 001-03-00012

Device Description : ELEOS™ INSTRUMENTATION TRAY, MALE-MALE MIDSECTION TRIALS, TRAY 12

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000130 Catalog Number : 001-03-00013

Device Description : ELEOS™ INSTRUMENTATION TRAY, AUGMENT PREPARATION AND TRIALING INSTRUMENTS, TRAY 13

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000140 Catalog Number : 001-03-00014

Device Description : ELEOS™ INSTRUMENTATION TRAY, PIN CADDY, KIT TO TRAY 8

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000150 Catalog Number : 001-03-00015

Device Description : ELEOS™ INSTRUMENTATION TRAY, TRAY LID SMALL

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000160 Catalog Number : 001-03-00016

Device Description : ELEOS™ INSTRUMENTATION TRAY, TRAY LID STANDARD

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000170 Catalog Number : 001-03-00017

Device Description : ELEOS™ INSTRUMENTATION TRAY, 17

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000180 Catalog Number : 001-03-00018

Device Description : ELEOS™ INSTRUMENTATION TRAY, 18

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000190 Catalog Number : 001-03-00019

Device Description : ELEOS™ INSTRUMENTATION TRAY, 19

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ELEOS™ - B27800103000200 Catalog Number : 001-03-00020

Device Description : ELEOS™ INSTRUMENTATION TRAY, 20

Device Class : 1

Duns Number: 080254074

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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