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) (5) Anti fog solution and accessories, endoscopy (OCT) (2) COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) (HIN) (2) INSUFFLATOR, LAPAROSCOPIC (HIF) (1)

Premarket Exempt

No Yes

Clear

Electro Lavage MG - 00817984010846 Catalog Number : 0600-MG3122-000

Device Description : Electro Lavage MG J Hook Dual Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage MG - 00817984010853 Catalog Number : 0600-MG3123-000

Device Description : Electro Lavage MG J Hook Double Bottle

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage MG - 00817984010860 Catalog Number : 0600-MG3131-000

Device Description : Electro Lavage MG Loop Single Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage MG - 00817984010877 Catalog Number : 0600-MG3132-000

Device Description : Electro Lavage MG Loop Dual Spike

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Electro Lavage MG - 00817984010884 Catalog Number : 0600-MG3133-000

Device Description : Electro Lavage MG Loop Double Bottle

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Needle Counter Box - 00817984010891 Catalog Number : 0600-NC101-000

Device Description : Needle Counter Box

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : OCT

Prescription Use : Yes

Device Count : 1

Bipolar Forceps - 00817984010907 Catalog Number : 0600-BC3310-000

Device Description : Bipolar Forceps Kleppinger-Style BC 34CM

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIN

Prescription Use : Yes

Device Count : 1

Bipolar Forceps - 00817984010914 Catalog Number : 0600-BC3320-000

Device Description : Bipolar Forceps Kleppinger-Style BC 45CM

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIN

Prescription Use : Yes

Device Count : 1

Filter Line MG - 00817984010921 Catalog Number : 0600-MG2007-000

Device Description : Filter Line MG Luer Connector

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : HIF

Prescription Use : Yes

Device Count : 1

Mr. Clear Purple - 00817984010938 Catalog Number : 0600-AF131-000

Device Description : Mr. Clear Purple Needle Counter Box

Device Class : 2

Duns Number: 606939072

Premarket Exempt : No

Product Code : OCT

Prescription Use : Yes

Device Count : 1

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