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

Accessories, Traction (ILZ) (1) Device, Transfer, Patient, Manual (FMR) (1)

Premarket Exempt

Yes

Clear

Arm Cradle - 00810006684186 Catalog Number : AC01

Device Description : Arm Cradle

Device Class : 1

Duns Number: 958758146

Premarket Exempt : Yes

Product Code : ILZ

Prescription Use : No

Device Count : 1

Glide & Guide Turn System Kit - 00810006684193 Catalog Number : GGTS07B

Device Description : GGTS07B Glide & Guide Turn System Kit Includes: 1 each - GGS5670 and 1 set - BPW GGTS07B Glide & Guide Turn System Kit Includes: 1 each - GGS5670 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

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