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

Non-Surgical Isolation Gown (OEA) (7) Gown, Examination (FME) (2) Dress, Surgical (FYE) (1)

Premarket Exempt

No Yes

Clear

Protexer - 00813360021369 Catalog Number : ICP-8200

Device Description : Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuff Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuffs, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexer - 00813360021376 Catalog Number : ICP-8250

Device Description : Dental Gown, SMS, Velcro Neck Closure, AAMI II, Yellow, Full Coverage, Knit Cuffs, 2XL

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexer - 00813360021390 Catalog Number : ICP-3845

Device Description : Gown, Polyethylene, Blue, Thumb Loop, Over the Head, Open Back, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FYE

Prescription Use : No

Device Count : 1

ICP - 00813360021482 Catalog Number : RR-300XL

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

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

ICP - 00813360021499 Catalog Number : RR-300XXL

Device Description : Open Back Gown, Poly-Coated, Over the Head, Thumbloop with Elastic Wrist, 2XL

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 1

Protexter - 00813360021505 Catalog Number : 8150

Device Description : Universal Comfort Gown

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexer - 00813360021536 Catalog Number : ICP-5050Y

Device Description : Open Back Gown - Polycoated, Yellow, Over the Head, Open Back, Thumb Loop and El Open Back Gown - Polycoated, Yellow, Over the Head, Open Back, Thumb Loop and Elastic Wrist, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexer - 00813360021550 Catalog Number : ICP-7050C

Device Description : Procedure Gown, Tested for Chemotherapy Drugs, White, Over the Head, Knit Cuffs, Procedure Gown, Tested for Chemotherapy Drugs, White, Over the Head, Knit Cuffs, Open Back, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexter - 00813360021567 Catalog Number : ICP-7053FCC

Device Description : Procedure Gown, PE Coating White, Over the Head, Knit Cuffs, Full Coverage, Universal

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

Protexer - 00813360021574 Catalog Number : ICP-7052FCC

Device Description : Procedure Gown, PE Coating, White, Over the Head, Knit Cuffs, Full Coverage, XL

Device Class :

Duns Number: 078780963

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 1

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