EXCELERON MEDICAL, INC.

EXCELERON MEDICAL, INC.

Address:5000 Township Pkwy,Saint Paul,MN,55110,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

Disinfectant, Medical Devices (LRJ) (10)

Premarket Exempt

No Yes

Clear

Nuwave - 00812970012002 Catalog Number : NW-001

Device Description : NUWAVE Generator

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012019 Catalog Number : NW-002

Device Description : NUWAVE with Small Bag

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012026 Catalog Number : NW-003

Device Description : NUWAVE with Large Bag

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012033 Catalog Number : NW-004

Device Description : NUWAVE with Small and Large Bag

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012040 Catalog Number : USB-PWR-ADPT-UL

Device Description : NUWAVE Power Supply

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012057 Catalog Number : USB-PWR-CORD

Device Description : NUWAVE Power Cord

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012064 Catalog Number : USB-PWR-ADPT-KIT

Device Description : NUWAVE Power Supply and Cord

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012071 Catalog Number : NUWAVE-BG-SM

Device Description : NUWAVE Small Bag

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012088 Catalog Number : NUWAVE-BG-LG

Device Description : NUWAVE Large Bag

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Nuwave - 00812970012095 Catalog Number : CO-001

Device Description : NUWAVE Ozone Filter

Device Class : 1

Duns Number: 825179992

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

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