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) (7) INSUFFLATOR, LAPAROSCOPIC (HIF) (2) CATHETER, IRRIGATION (GBX) (1)

Premarket Exempt

No Yes

Clear

Electro Lavage - 00817984010549 Catalog Number : 0600-3132-000

Device Description : Electro Lavage Loop Dual Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010556 Catalog Number : 0600-3133-000

Device Description : Electro Lavage

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010563 Catalog Number : 0600-3140-000

Device Description : Electro Lavage Needle

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010570 Catalog Number : 0600-3141-000

Device Description : Electro Lavage Needle Single Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010587 Catalog Number : 0600-3142-000

Device Description : Electro Lavage Needle Dual Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010594 Catalog Number : 0600-3143-000

Device Description : Electro Lavage Needle Double Bottle

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage - 00817984010600 Catalog Number : 0600-3150-000

Device Description : Electro Lavage Blunt

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Insufflation Needle - 00817984010655 Catalog Number : 0600-6120-000

Device Description : Insufflation Needle 120MM

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Insufflation Needle - 00817984010662 Catalog Number : 0600-6150-000

Device Description : Insufflation Needle 150MM

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Laser Lavage MG - 00817984010730 Catalog Number : 0600-MG3011-000

Device Description : Laser Lavage MG Single Spike

Device Class : 1

Duns Number: 606939072

Premarket Exempt : No

Product Code : GBX

Prescription Use : Yes

Device Count : 1

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