PRIMO INC

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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

Device, Transfer, Patient, Manual (FMR) (7) Protector, Skin Pressure (FMP) (3)

Premarket Exempt

Yes

Clear

Glide & Guide Turn Sheet - 00810006680409 Catalog Number : GGS4460SS

Device Description : Glide & Guide Turn Sheet (44" x 60") w/ Side Straps

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet - 00810006680416 Catalog Number : GGS4460TS

Device Description : Glide & Guide Turn Sheet (44" x 60") w/ Top Straps

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet Select - 00810006680423 Catalog Number : GGS5660F

Device Description : Glide & Guide Turn Sheet - Bariatric (56" x 60")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet - 00810006680430 Catalog Number : GGS5660SS

Device Description : Glide & Guide Turn Sheet - Bariatric (56" x 60") w/ Side Straps

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet Select - 00810006680447 Catalog Number : GGS5660SSF

Device Description : Select Glide & Guide Turn Sheet - Bariatric (56" x 60") w/ Side Straps

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet - 00810006680454 Catalog Number : GGS5660TS

Device Description : Glide & Guide Turn Sheet - Bariatric (56" x 60") w/ Top Straps

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn Sheet Select - 00810006680461 Catalog Number : GGS5660TSF

Device Description : Select Glide & Guide Turn Sheet - Bariatric (56" x 60") w/ Top Straps

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

HeelCheck - 00810006680478 Catalog Number : HCB

Device Description : HeelCheck - Bariatric

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Guardian Heel Protector - 00810006680485 Catalog Number : HP201

Device Description : Guardian Heel Protector, Black/Khaki

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Guardian Heel Protector - 00810006680492 Catalog Number : HP201N

Device Description : Guardian Heel Protector, Navy/Gray

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

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