AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.

Address:28703 INDUSTRY DR,Valencia,CA,91355,US

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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

Dental Barriers And Sleeves (PEM) (6) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (4)

Premarket Exempt

No Yes

Clear

Patient Armor Sterilization Pouches - 00858653006005 Catalog Number : AMH-210

Device Description : Patient Armor Sterilization Pouches 2.75 x 10" - 200/Bx

Device Class : 2

Duns Number: 180611519

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Patient Armor Sterilization Pouches - 00858653006012 Catalog Number : AMH-305

Device Description : Patient Armor Sterilization Pouches 3.5 x 6.5" - 200/Bx

Device Class : 2

Duns Number: 180611519

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Patient Armor Sterilization Pouches - 00858653006029 Catalog Number : AMH-3510

Device Description : Patient Armor Sterilization Pouches 3.5 x 10" - 200/Bx

Device Class : 2

Duns Number: 180611519

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Patient Armor Sterilization Pouches - 00858653006036 Catalog Number : AMH-511

Device Description : Patient Armor Sterilization Pouches 5.25 x11" - 200/Bx

Device Class : 2

Duns Number: 180611519

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Patient Armor Barriers - 00858653006074 Catalog Number : AM-006CSH

Device Description : Patient Armor Chair Sleeves- Half 27.5" x 24" - 225/Bx

Device Class :

Duns Number: 180611519

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1

Patient Armor Barriers - 00858653006081 Catalog Number : AM-006CSF

Device Description : Patient Armor Chair Sleeves- Full 29" x 80" - 125/Bx

Device Class :

Duns Number: 180611519

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1

Patient Armor Barriers - 00858653006098 Catalog Number : AM-006HR911

Device Description : Patient Armor Headrest Covers 11" x 9.5" x 2" - 250/Bx

Device Class :

Duns Number: 180611519

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1

Patient Armor Barriers - 00858653006104 Catalog Number : AM-006HR914

Device Description : Patient Armor Headrest Covers 14" x 9.5 x 2" - 250/Bx

Device Class :

Duns Number: 180611519

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1

Patient Armor Barriers - 00858653006111 Catalog Number : AM-006SSB

Device Description : Patient Armor Syringe Sleeves 2.5" x 10" Blue - 500/Bx

Device Class :

Duns Number: 180611519

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1

Patient Armor Barriers - 00858653006128 Catalog Number : AM-006SSC

Device Description : Patient Armor Syringe Sleeves 2.5" x 10" Clear - 500/Bx

Device Class :

Duns Number: 180611519

Premarket Exempt : No

Product Code : PEM

Prescription Use : No

Device Count : 1

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