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) INSUFFLATOR, LAPAROSCOPIC (HIF) (2) Anti fog solution and accessories, endoscopy (OCT) (1) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1)

Premarket Exempt

No Yes

Clear

Mr. Clear Purple - 00817984010945 Catalog Number : 0600-AF031-NF-000

Device Description : Mr. Clear Purple No Foam Pad

Device Class :

Duns Number: 606939072

Premarket Exempt : No

Product Code : OCT

Prescription Use : Yes

Device Count : 1

Bahama Hook - 00817984010969 Catalog Number : 0600-1011-000

Device Description : Bahama Hook

Device Class : 1

Duns Number: 606939072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Line - 00817984010976 Catalog Number : 0600-2020-000

Device Description : Line Barb Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Filter Line - 00817984010983 Catalog Number : 0600-2030-000

Device Description : Smoke Master

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Tube Set - 00817984010990 Catalog Number : 0600-2102-000

Device Description : Pump & Vacuum

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tube Set - 00817984011003 Catalog Number : 0600-2129-000

Device Description : Dual Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tube Set - 00817984011010 Catalog Number : 0600-2132-000

Device Description : Lap Vac-Irrigator

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tube Set - 00817984011027 Catalog Number : 0600-2139-000

Device Description : Double Bottle

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Line - 00817984011034 Catalog Number : 0600-2150-000

Device Description : Single Spike Saline

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Line - 00817984011041 Catalog Number : 0600-2152-000

Device Description : Dual Spike Saline

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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