MECTRON SPA

Address:15, VIA LORETO,CARASCO Genova,IT

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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

Drill, Bone, Powered (DZI) (10) Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (ERL) (10) Drills, Burrs, Trephines & Accessories (Simple, Powered) (HBE) (10) Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (HWE) (10) Instrument, Surgical, Sonic And Accessory/Attachment (JDX) (10)

Premarket Exempt

Clear

MECTRON - E322036000140 Catalog Number : 03600014

Device Description : MT4-20 + is an osteotomy surgical insert to be used in conjunction with Mectron MT4-20 + is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery handpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

MECTRON - E322036000150 Catalog Number : 03600015

Device Description : MT10-20+ is an osteotomy surgical insert to be used in conjuction with Mectron P MT10-20+ is an osteotomy surgical insert to be used in conjuction with Mectron Piezosurgery handpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

MECTRON - E322036000160 Catalog Number : 03600016

Device Description : MT9-13 is and osteotomy surgical insert to be used in conjuction with Mectron Pi MT9-13 is and osteotomy surgical insert to be used in conjuction with Mectron Piezosurgery hanpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

MECTRON - E322036000170 Catalog Number : 03600017

Device Description : MT11R-10 is an osteotomy surgical insert to be used in conjunction with Mectron MT11R-10 is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery handpieces

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

MECTRON - E322036000180 Catalog Number : 03600018

Device Description : MT11L-10 is an osteotomy surgical insert to be used in conjunction wit Mectron P MT11L-10 is an osteotomy surgical insert to be used in conjunction wit Mectron Piezosurgery handpieces

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

MECTRON - E322036100010 Catalog Number : 03610001

Device Description : MP1 is a surgical insert for osteoplasty procedures to be used in conjunction wi MP1 is a surgical insert for osteoplasty procedures to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, JDX, DZI

Prescription Use : Yes

Device Count : 1

MECTRON - E322036100020 Catalog Number : 03610002

Device Description : MP2 is a surgical insert for osteoplasty procedures to be used in conjunction wi MP2 is a surgical insert for osteoplasty procedures to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, JDX, DZI

Prescription Use : Yes

Device Count : 1

MECTRON - E322036100030 Catalog Number : 03610003

Device Description : MP3-a30 is a surgical insert for osteoplasty procedures to be used in conjunctio MP3-a30 is a surgical insert for osteoplasty procedures to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

MECTRON - E322036100070 Catalog Number : 03610007

Device Description : MP4 + is a surgical insert for osteoplasty procedures to be used in conjunction MP4 + is a surgical insert for osteoplasty procedures to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

MECTRON - E322036100080 Catalog Number : 03610008

Device Description : MP5 L is a surgical insert for osteoplasty procedures to be used in conjunction MP5 L is a surgical insert for osteoplasty procedures to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.

Device Class : 1

Duns Number: 436664734

Premarket Exempt : No

Product Code : HWE, HBE, ERL, DZI, JDX

Prescription Use : Yes

Device Count : 1

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