Conmed Corporation

Address:134 Flanders Rd,WESTBOROUGH,MA,01581,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

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (6) INSUFFLATOR, LAPAROSCOPIC (HIF) (2) TRAY, SURGICAL, INSTRUMENT (FSM) (2)

Premarket Exempt

No Yes

Clear

Infinity - 30845854902275 Catalog Number : KTS135

Device Description : Infinity 3.5mm All-Inside Guide Sleeve

Device Class :

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Infinity - 30845854902282 Catalog Number : KGB100

Device Description : Infinity Guide Body

Device Class : 1

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Infinity - 30845854902299 Catalog Number : KBL178

Device Description : Infinity Anteromedial Guide Left 7/8mm

Device Class : 1

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Infinity - 30845854902305 Catalog Number : KBL191

Device Description : Infinity Anteromedial Guide Left 9/10mm

Device Class : 1

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Infinity - 30845854902312 Catalog Number : KBR178

Device Description : Infinity Anteromedial Guide Right 7/8mm

Device Class : 1

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Infinity - 30845854902329 Catalog Number : KBR191

Device Description : Infinity Anteromedial Guide Right 9/10mm

Device Class : 1

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

CONMED - 30845854902664 Catalog Number : INST-LBRM01

Device Description : Shoulder Instability Insert Tray

Device Class : 1

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

CONMED - 30845854902671 Catalog Number : INST-CFK02A

Device Description : Shoulder Accessories Insert Tray #1

Device Class : 1

Duns Number: 071595540

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

AIRSEAL - 30851885004581 Catalog Number : AS-iFS1

Device Description : AIRSEAL IFS, 110V

Device Class : 2

Duns Number: 071595540

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

AIRSEAL - 30851885004598 Catalog Number : AS-iFS2

Device Description : AIRSEAL IFS, 230V

Device Class : 2

Duns Number: 071595540

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

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