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

General Surgery Tray (LRO) (4) Orthopedic Tray (OJH) (3) Labor And Delivery Kit (MLS) (2) Custom Anesthesia Tray (OGD) (1)

Premarket Exempt

No Yes

Clear

Regard™ - 10194717116189 Catalog Number :

Device Description : PK CUST SETUP

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116196 Catalog Number :

Device Description : OB

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : MLS

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116202 Catalog Number :

Device Description : MINOR

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116219 Catalog Number :

Device Description : LOCAL

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OGD

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116226 Catalog Number :

Device Description : OB PACK

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : MLS

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116233 Catalog Number :

Device Description : MAIN OR

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116240 Catalog Number :

Device Description : HAND

Device Class : 1

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116257 Catalog Number :

Device Description : Hand

Device Class : 1

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116264 Catalog Number :

Device Description : CORE BIOPSY

Device Class : 2

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Regard™ - 10194717116271 Catalog Number :

Device Description : TOTAL KNEE

Device Class : 1

Duns Number: 117174678

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

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