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

Electrosurgical, cutting & coagulation & accessories (GEI) (10)

Premarket Exempt

No Yes

Clear

Electro Lavage - 00817984010440 Catalog Number : 0600-3110-000

Device Description : Electro Lavage L Hook

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010457 Catalog Number : 0600-3111-000

Device Description : Electro Lavage L Hook Single Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010464 Catalog Number : 0600-3112-000

Device Description : Electro Lavage L Hook Dual Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010471 Catalog Number : 0600-3113-000

Device Description : Electro Lavage L Hook Double Bottle

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010488 Catalog Number : 0600-3120-000

Device Description : Electro Lavage J Hook

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010495 Catalog Number : 0600-3121-000

Device Description : Electro Lavage J Hook Single Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010501 Catalog Number : 0600-3122-000

Device Description : Electro Lavage J Hook Dual Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010518 Catalog Number : 0600-3123-000

Device Description : Electro Lavage J Hook Double Bottle

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010525 Catalog Number : 0600-3130-000

Device Description : Electro Lavage Loop

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010532 Catalog Number : 0600-3131-000

Device Description : Electro Lavage Loop Single Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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