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

Electrode, Electrocardiograph, Multi-Function (MLN) (4) I.V. Start Kit (LRS) (3) General Surgery Tray (LRO) (1) Indicator, Physical/Chemical Sterilization Process (JOJ) (1) Suture Kit (OVN) (1)

Premarket Exempt

No Yes

Clear

Regard™ - 00326053105661 Catalog Number : 315728REG

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Regard™ - 00326053105685 Catalog Number : 315730REG

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Regard™ - 00326053105692 Catalog Number : 315731REG

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Regard™ - 00326053105739 Catalog Number : 315735REG

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

Regard™ - 00326053105746 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

Regard™ - 00326053109300 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : No

Device Count : 1

Regard™ - 00326053109331 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : LRS

Prescription Use : No

Device Count : 1

Regard™ - 00326053109355 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : LRS

Prescription Use : No

Device Count : 1

Regard™ - 00326053109362 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : OVN

Prescription Use : No

Device Count : 1

Regard™ - 00326053115936 Catalog Number :

Device Class : 2

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : LRS

Prescription Use : No

Device Count : 1

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