IRRIMAX CORPORATION

Address:1665 Lakes Parkway,Lawrenceville,GA,30043,US

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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

LAVAGE, JET (FQH) (8) Dressing, wound, drug (FRO) (3) SYRINGE, IRRIGATING (NON DENTAL) (KYZ) (1)

Premarket Exempt

No Yes

Clear

Irrimax - 10842351100025 Catalog Number : 0002

Device Description : Irrimax Wound Irrigation System

Device Class :

Duns Number: 142661078

Premarket Exempt : Yes

Product Code : KYZ

Prescription Use : Yes

Device Count : 12

Irrisept - 10842351100032 Catalog Number : 0003

Device Description : Irrisept Wound Debridment and Cleansing System

Device Class :

Duns Number: 142661078

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 6

Irrisept - 10842351100056 Catalog Number : 0005

Device Description : Clinical Research Wound Debridment and Cleansing System

Device Class :

Duns Number: 142661078

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 6

Irrisept - 10842351110000 Catalog Number : 1000

Device Description : Irrisept Wound Debridment and Cleansing System

Device Class :

Duns Number: 142661078

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 12

Irrisept Antimicrobial Wound Lavage - 10842351110093 Catalog Number :

Device Description : 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrig 450 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.

Device Class : 2

Duns Number: 142661078

Premarket Exempt : No

Product Code : FQH, FRO

Prescription Use : Yes

Device Count : 12

Irrisept Antimicrobial Wound Lavage - 10842351120009 Catalog Number :

Device Description : 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrig 150 mL bottle of 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP and applicator.

Device Class : 2

Duns Number: 142661078

Premarket Exempt : No

Product Code : FRO, FQH

Prescription Use : Yes

Device Count : 15

Irrisept - 10842351180003 Catalog Number : 8000

Device Description : Irrisept Wound Debridment and Cleansing System

Device Class :

Duns Number: 142661078

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 21

Irrisept Antimicrobial Wound Lavage - 10842351190002 Catalog Number : 9000

Device Class :

Duns Number: 142661078

Premarket Exempt : No

Product Code : FQH, FRO

Prescription Use : Yes

Device Count : 12

Irrisept - 10842351190019 Catalog Number : 9001

Device Description : Irrisept Wound Debridment and Cleansing System

Device Class :

Duns Number: 142661078

Premarket Exempt : No

Product Code : FQH

Prescription Use : Yes

Device Count : 12

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