RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Address:645 Maryville Centre Drive, Suite 200,Saint Louis,MO,63141,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

Neurological Tray (OJG) (4) Gynecological Laparoscopic Kit (OHD) (2) Orthopedic Tray (OJH) (2) Cardiovascular Procedure Kit (OEZ) (1) Port Introducer Kit (OKE) (1)

Premarket Exempt

No Yes

Clear

Regard™ - 10326053116404 Catalog Number :

Device Class : 2

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OEZ

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116435 Catalog Number :

Device Class : 2

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OHD

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116442 Catalog Number :

Device Class : 2

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OHD

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116466 Catalog Number :

Device Class : 1

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OJG

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116473 Catalog Number :

Device Class : 1

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OJG

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116480 Catalog Number :

Device Class : 1

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OJG

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116497 Catalog Number :

Device Class : 1

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OJG

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116633 Catalog Number :

Device Class :

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116640 Catalog Number :

Device Class : 2

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OKE

Prescription Use : Yes

Device Count : 1

Regard™ - 10326053116695 Catalog Number :

Device Class : 1

Duns Number: 945020902

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

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