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) (5) Protector, Skin Pressure (FMP) (5)

Premarket Exempt

Yes

Clear

PRIMOBoot, Black/Gray - Small - 00810006683912 Catalog Number : BABBSW

Device Description : PRIMOBoot w/wedge, Black/Gray - Small

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Defender - Standard - 00810006683998 Catalog Number : HB100

Device Description : Defender - Standard

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

PRIMOBoot, Black/Gray - Small - 00810006684001 Catalog Number : BABBS

Device Description : PRIMOBoot, Black/Gray - Small

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Defender - Small - 00810006684018 Catalog Number : HB100S

Device Description : Defender - Small

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Defender - Bariatric - 00810006684025 Catalog Number : HB100B

Device Description : Defender - Bariatric

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

Economy Glide & Guide Turn Sheet - 00810006684032 Catalog Number : GGE3660

Device Description : Economy Glide & Guide Turn Sheet (36" x 60")

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Economy Glide & Guide Turn Sheet - 00810006684049 Catalog Number : GGE5660

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

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn System Kit - 00810006684056 Catalog Number : GGTS05

Device Description : GGTS05 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW1 GGTS05 Glide & Guide Turn System Kit Includes: 1 each - GGS3660 and 1 set - BPW11R; 10 Kit/Case

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn System Kit - 00810006684063 Catalog Number : GGTS05B

Device Description : GGTS05B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW GGTS05B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW11R; 10 Kit/Case

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Glide & Guide Turn System Kit - 00810006684070 Catalog Number : GGTS06B

Device Description : GGTS06B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW GGTS06B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW11F; 12 Kit/Case

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

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