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) (8) INSUFFLATOR, LAPAROSCOPIC (HIF) (2)

Premarket Exempt

No Yes

Clear

Master Lavage - 00817984010006 Catalog Number : 0600-3001-000

Device Description : Master Lavage Single Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Master Lavage - 00817984010013 Catalog Number : 0600-3002-000

Device Description : Master Lavage Dual Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Master Lavage - 00817984010020 Catalog Number : 0600-3003-000

Device Description : Master Lavage Double Bottle

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Ethicon EPT01 - 00817984010037 Catalog Number : 0600-2149-000

Device Description : Dual Bottle Irrigation Tube Set

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Ethicon EPT03 - 00817984010044 Catalog Number : 0600-2159-000

Device Description : Pressurized Bag Irrigation Tube Set With Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Laser Lavage - 00817984010051 Catalog Number : 0600-3011-000

Device Description : Laser Lavage Single Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Laser Lavage - 00817984010068 Catalog Number : 0600-3012-000

Device Description : Laser Lavage Dual Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Laser Lavage - 00817984010075 Catalog Number : 0600-3013-000

Device Description : Laser Lavage Double Bottle

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Filter Line - 00817984010082 Catalog Number : 0600-2010-000

Device Description : Filter Line Barb Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Filter Line - 00817984010099 Catalog Number : 0600-2107-000

Device Description : Filter Line Quick Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

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