SKYLINE MEDICAL INC.

Address:2915 Commers Dr Ste 900,Eagan,MN,55121,US

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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

Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (4)

Premarket Exempt

Clear

Streamway - 10862675000306 Catalog Number : STM 2000

Device Description : Direct to drain liquid fluid waste management system

Device Class : 2

Duns Number: 024774680

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

Streamway Filter - 10862675000313 Catalog Number : STM 2015

Device Description : Procedure Filter for Streamway device

Device Class : 2

Duns Number: 024774680

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

Streamway Cleaner - 10862675000320 Catalog Number : STM 20032016-09-23

Device Description : Cleaning Fluid for Device

Device Class : 2

Duns Number: 024774680

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

STM 2000 PM Kit - 10862675000337 Catalog Number : PM1005

Device Description : Preventative Maintenance Kit

Device Class : 2

Duns Number: 024774680

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

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