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) (5) Anti fog solution and accessories, endoscopy (OCT) (2) INSUFFLATOR, LAPAROSCOPIC (HIF) (2) Electrosurgical, cutting & coagulation & accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

Tube Set - 00817984011058 Catalog Number : 0600-2203-000

Device Description : Sinus Vacu-Irrigator

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Filter - 00817984011065 Catalog Number : 0600-2307-000

Device Description : High Flow

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Line - 00817984011072 Catalog Number : 0600-2350-000

Device Description : Single Spike Saline With Clamps

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Tube Set - 00817984011089 Catalog Number : 0600-2450-000

Device Description : High Flow Irrigation

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tissue Sample Retainer - 00817984011096 Catalog Number : 0600-9001-000

Device Description : Tissue Sample Retainer 125

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tissue Sample Retainer - 00817984011102 Catalog Number : 0600-9002-000

Device Description : Tissue Sample Retainer 250

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tissue Sample Retainer - 00817984011119 Catalog Number : 0600-9003-000

Device Description : Tissue Sample Retainer 500

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Mr. Clear Purple - 00817984011126 Catalog Number : 0600-AF031-GER-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

Mr. Clear Purple - 00817984011133 Catalog Number : 0600-AF031-KR1-000

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 - 00817984011140 Catalog Number : 0600-EL102-KR1-000

Device Description : Electro Lube Pouch

Device Class :

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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