MECTRA LABS, INC.

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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

CATHETER, IRRIGATION (GBX) (6) Electrosurgical, cutting & coagulation & accessories (GEI) (2) Anti fog solution and accessories, endoscopy (OCT) (1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1)

Premarket Exempt

No Yes

Clear

Mr. Clear Purple - 00817984010204 Catalog Number : 0600-AF031-000

Device Description : Mr. Clear Purple Foam Pad

Device Class :

Duns Number: 606939072

Premarket Exempt : No

Product Code : OCT

Prescription Use : Yes

Device Count : 1

Electro Lube - 00817984010211 Catalog Number : 0600-EL101-000

Device Description : Electro Lube Bottle

Device Class :

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lube - 00817984010228 Catalog Number : 0600-EL102-000

Device Description : Electro Lube Pouch

Device Class :

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Master Lavage MG - 00817984010273 Catalog Number : 0600-MG3001-000

Device Description : Master Lavage MG Single Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Master Lavage MG - 00817984010280 Catalog Number : 0600-MG3002-000

Device Description : Master Lavage MG Dual Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Master Lavage MG - 00817984010297 Catalog Number : 0600-MG3003-000

Device Description : Master Lavage MG Double Bottle

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Bahama Blade - 00817984010303 Catalog Number : 0600-1001-000

Device Description : Bahama Blade

Device Class : 1

Duns Number: 606939072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lav-1 Laser - 00817984010310 Catalog Number : 0600-3008-000

Device Description : Lav-1 Laser

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Vozzle - 00817984010327 Catalog Number : 0600-1221-000

Device Description : Vozzle Vacu-Irrigator SS

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Vozzle - 00817984010334 Catalog Number : 0600-1222-000

Device Description : Vozzle Vacu-Irrigator DS

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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