ICP MEDICAL, LLC

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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, Examination (FME) (4) Non-Surgical Isolation Gown (OEA) (4) Cover, Mattress (Medical Purposes) (FMW) (2)

Premarket Exempt

No Yes

Clear

Protexer - 00813360021581 Catalog Number : ICP-8300

Device Description : Open Back Gown, SMS, Yellow, Over the Head, Thumb Loop with Elastic Wrist, 3XL

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexter - 00813360021598 Catalog Number : ICP-8150FC

Device Description : Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Isolation gown, SMS, AAMI Level II, Yellow, Over the Head, Full Coverage, Thumb Loop with Elastic Wrist, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexer - 00813360021611 Catalog Number : ICP-8700

Device Description : Isolation Gown, White, AAMI Level 2, SMS, Over the Head, Full Coverage, Thumbloo Isolation Gown, White, AAMI Level 2, SMS, Over the Head, Full Coverage, Thumbloop, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

ICP - 00813360021628 Catalog Number : ICP-9001GUR

Device Description : Universal Mattress Cover

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : No

Device Count : 1

ICP - 00813360021635 Catalog Number : ICP-9003GUR

Device Description : 2XXL White Universal Mattress Cover

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : No

Device Count : 1

Protexter - 00813360021642 Catalog Number : RR-100

Device Description : Universal Comfort Gown

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Protexter - 00813360021659 Catalog Number : RR-200

Device Description : Open Back Gown, SMS, Over the Head, Thumbloop with Elastic Wrist, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Protexter - 00813360021666 Catalog Number : RR-300

Device Description : Open Back Gown, Poly-Coated, Over the Head, Thumbloop with Elastic Wrist, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Protexter - 00813360021673 Catalog Number : RR-330BFC

Device Description : Full Coverage

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Protexer - 00813360021727 Catalog Number : RR-500

Device Description : Chemotherapy Gown,AAMI Level 2, ASTM F739 Tested, Purple, Velcro Tab, Knit Cuffs Chemotherapy Gown,AAMI Level 2, ASTM F739 Tested, Purple, Velcro Tab, Knit Cuffs, Purple, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

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