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) (4)

Premarket Exempt

No Yes

Clear

Tube Set - 00817984010341 Catalog Number : 0600-2000-000

Device Description : Tube Set Bifurcated Single Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Tube Set - 00817984010358 Catalog Number : 0600-2100-000

Device Description : Tube Set Bifurcated Dual Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Laser Lavage - 00817984010365 Catalog Number : 0600-3021-000

Device Description : Laser Lavage 32CM Single Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Master Lavage - 00817984010372 Catalog Number : 0600-3022-000

Device Description : Master Lavage 36CM Dual Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Master Lavage - 00817984010389 Catalog Number : 0600-3023-000

Device Description : Master Lavage 36CM Double Bottle

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Master Lavage - 00817984010396 Catalog Number : 0600-3041-000

Device Description : Master Lavage Filter

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010402 Catalog Number : 0600-3100-000

Device Description : Electro Lavage Spatula

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010419 Catalog Number : 0600-3101-000

Device Description : Electro Lavage Spatula Single Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010426 Catalog Number : 0600-3102-000

Device Description : Electro Lavage Spatula Dual Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010433 Catalog Number : 0600-3103-000

Device Description : Electro Lavage Spatula Double Bottle

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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