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

INSUFFLATOR, LAPAROSCOPIC (HIF) (7) Anti fog solution and accessories, endoscopy (OCT) (3)

Premarket Exempt

No Yes

Clear

Filter Line - 00817984010105 Catalog Number : 0600-2110-000

Device Description : Filter Line Luer Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Filter Line - 00817984010112 Catalog Number : 0600-2407-000

Device Description : Filter Line 22MM Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Filter Line - 00817984010129 Catalog Number : 0600-2507-000

Device Description : Filter Line ISO Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Mr. Clear Purple - 00817984010136 Catalog Number : 0600-AF041-000

Device Description : Dry To The Touch

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : OCT

Prescription Use : Yes

Device Count : 1

Filter Line MG - 00817984010143 Catalog Number : 0600-MG2010-000

Device Description : Filter Line MG Barb Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Filter Line MG - 00817984010150 Catalog Number : 0600-MG2107-000

Device Description : Filter Line MG Quick Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Filter Line MG - 00817984010167 Catalog Number : 0600-MG2407-000

Device Description : Filter Line MG 22MM Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Filter Line MG - 00817984010174 Catalog Number : 0600-MG2507-000

Device Description : Filter Line MG ISO Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Mr. Clear Purple - 00817984010181 Catalog Number : 0600-AF011-000

Device Description : Mr. Clear Purple Wipe

Device Class :

Duns Number: 606939072

Premarket Exempt : No

Product Code : OCT

Prescription Use : Yes

Device Count : 1

Mr. Clear Purple - 00817984010198 Catalog Number : 0600-AF001-000

Device Description : Mr. Clear Purple Dobber Top

Device Class :

Duns Number: 606939072

Premarket Exempt : No

Product Code : OCT

Prescription Use : Yes

Device Count : 1

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