ROI CPS, LLC

ROI CPS, LLC

Address:3000 E SAWYER RD,Republic,MO,65738,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

Cardiovascular Procedure Kit (OEZ) (2) General Surgery Tray (LRO) (2) Laparoscopy Kit (FDE) (1) Neurological Tray (OJG) (1) Orthopedic Tray (OJH) (1) Burn Kit Without Drug (OJJ) (1) Tray, Surgical (LRP) (1) Cardiac Catheterization Kit (OES) (1)

Premarket Exempt

No Yes

Clear

Regard™ - 10194717100027 Catalog Number :

Device Class : 1

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100034 Catalog Number :

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OES

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100041 Catalog Number :

Device Class : 1

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100058 Catalog Number :

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : FDE

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100065 Catalog Number :

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100072 Catalog Number :

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100089 Catalog Number :

Device Class : 1

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OJJ

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100096 Catalog Number :

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OEZ

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100102 Catalog Number :

Device Class : 1

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OJG

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717100119 Catalog Number :

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OEZ

Prescription Use : Yes

Device Count : 1

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