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

Gown, Surgical (FYA) (6) Mask, Surgical (FXX) (2) Accessory, Surgical Apparel (LYU) (1) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (1)

Premarket Exempt

No Yes

Clear

Regard™ - 00326053117480 Catalog Number : 382952

Device Description : BOUFFANT CAP, ELASTIC, DISPOSABLE, BLUE, 24IN, NS, LF

Device Class : 1

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 1

Regard™ - 00326053117558 Catalog Number : 382959

Device Description : AAMI3, SRG GWN, SET IN SLV, ST, S/M

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Regard™ - 00326053117565 Catalog Number : 382960

Device Description : AAMI3, SRG GWN, SET IN SLV, ST, L

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Regard™ - 00326053117572 Catalog Number : 382961

Device Description : AAMI3, SRG GWN, SET IN SLV, ST, XL

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Regard™ - 00326053117589 Catalog Number : 382962

Device Description : AAMI3, SRG GWN, SET IN SLV, ST, 2XL

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Regard™ - 00326053117596 Catalog Number : 382963

Device Description : AAMI3, SRG GWN, SET IN SLV, ST, 3XL

Device Class :

Duns Number: 134472476

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

SurgiPlus - 00326053117602 Catalog Number : 382965

Device Description : Set-in Sleeve AAMI 3 Sterile Surgical Gown, Size XL

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

Regard - 00326053117619 Catalog Number : 382966

Device Description : AAMI LEVEL 1, PROCEDURE MASK, EARLOOP, GREEN, NON STERILE, UNIVERSAL SIZE

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Regard™ - 00326053117695 Catalog Number :

Device Description : AAMI LEVEL 3, PROCEDURE MASK, EARLOOP, NON STERILE, UNIVERSAL SIZE

Device Class : 2

Duns Number: 134472476

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Regard - 00326053117749 Catalog Number :

Device Description : Goggles Without Ventilation, Universal Size

Device Class : 1

Duns Number: 134472476

Premarket Exempt : Yes

Product Code : HOY

Prescription Use : No

Device Count : 1

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