AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.

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

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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

Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (2) Mask, Surgical (FXX) (2) Material, Impression (ELW) (2)

Premarket Exempt

No Yes

Clear

Patient Armor Ear Loop Masks ASTM Level 2 - 00858653006296 Catalog Number : PA002P

Device Description : Fluid Resistant Earloop Mask ASTM Level 2 (Pink) - 50/Bx

Device Class : 2

Duns Number: 180611519

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Patient Armor Ear Loop Masks ASTM Level 2 - 00858653006302 Catalog Number : PA002W

Device Description : Fluid Resistant Earloop Mask ASTM Level 2 (White) - 50/Bx

Device Class : 2

Duns Number: 180611519

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 1

Helo Bite Registration - 00858653006319 Catalog Number : PA003FS

Device Description : Bite Registration - Fast Set - 2/pk

Device Class : 2

Duns Number: 180611519

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : No

Device Count : 1

Helo Bite Registration - 00858653006326 Catalog Number : PA003RS

Device Description : Bite Registration - Regular Set - 2/pk

Device Class : 2

Duns Number: 180611519

Premarket Exempt : Yes

Product Code : ELW

Prescription Use : No

Device Count : 1

BANZAI DPA Firm White 4-Web Cup - 00858653006630 Catalog Number : AM-3002

Device Description : BANZAI DPA Firm White 4-Web Cup - 100/Bx

Device Class : 1

Duns Number: 180611519

Premarket Exempt : No

Product Code : EGS

Prescription Use : No

Device Count : 1

BANZAI DPA Soft Gray 4-Web Cup - 00858653006647 Catalog Number : AM-3001

Device Description : BANZAI DPA Soft Gray 4-Web Cup - 100/Bx

Device Class : 1

Duns Number: 180611519

Premarket Exempt : No

Product Code : EGS

Prescription Use : No

Device Count : 1

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