Southmedic Incorporated

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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

Cleaner, ultrasonic, medical instrument (FLG) (10)

Premarket Exempt

No Yes

Clear

EcoBase - 10620974003363 Catalog Number : 11050-04

Device Description : EcoBase, Non-Enzymatic Detergent 1G

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 4

EcoBase - 10620974003394 Catalog Number : 11050-2.5

Device Description : EcoBase, Non-Enzymatic Detergent 2.5G

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 2

EcoZyme Auto - 10620974003400 Catalog Number : 17560-04

Device Description : EcoZyme Auto, Multi-Tiered Enzymatic Detergent 1G

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 4

EcoZyme Auto - 10620974003424 Catalog Number : 17560-2.5

Device Description : EcoZyme Auto, Multi-Tiered Enzymatic Detergent 2.5G

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 2

EcoZyme Ultra - 10620974003431 Catalog Number : 18560-04

Device Description : EcoZyme Ultra Enzymatic Detergent 1G

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 4

EcoZyme Ultra - 10620974003462 Catalog Number : 18560-2.5

Device Description : EcoZyme Ultra Enzymatic Detergent 2.5G

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 2

EcoZyme - 10620974003479 Catalog Number : 27545-16

Device Description : EcoZyme Spray 16 fl oz

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 12

EcoZyme - 10620974003486 Catalog Number : 27545-32

Device Description : EcoZyme Spray 32 fl oz

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 6

EcoSonic - 10620974003493 Catalog Number : 43394-04

Device Description : EcoSonic Descaler, 4G

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 4

EcoZyme - 10620974003509 Catalog Number : 27545-08

Device Description : EcoZyme Spray 8 fl oz

Device Class : 1

Duns Number: 246848147

Premarket Exempt : Yes

Product Code : FLG

Prescription Use : No

Device Count : 24

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