AMERICAN SURGICAL COMPANY, LLC

Address:45 Congress St,Salem,MA,01970,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

Neurosurgical Paddie (HBA) (7) Gauze/Sponge, Internal, X-Ray Detectable (GDY) (2) Sponge, Ophthalmic (HOZ) (1)

Premarket Exempt

No Yes

Clear

Ophthalmic Pledget - 20749915002566 Catalog Number : 111-02

Device Description : Ophthalmic Pledget 7/32"

Device Class :

Duns Number: 151054954

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : No

Device Count : 20

Tapered Delicot - 20749915002665 Catalog Number :

Device Description : Tapered Delicot 2 mm x 4 mm x 48 mm

Device Class : 2

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 20

Americot - 30749915000224 Catalog Number :

Device Description : Americot Blue 3/4" x 2"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 20

Americot - 30749915000316 Catalog Number :

Device Description : Americot White 1" x 6"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 20

Cotton Balls - 30749915000538 Catalog Number :

Device Description : Cotton Balls-Strung 3/8"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : GDY

Prescription Use : No

Device Count : 20

Cotton Balls - 30749915000613 Catalog Number :

Device Description : Cotton Balls-Non-Strung 1/4"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : GDY

Prescription Use : No

Device Count : 20

Ray-Cot - 30749915000903 Catalog Number :

Device Description : Ray-Cot 1" x 1"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 20

Telfa - 30749915001764 Catalog Number :

Device Description : Telfa 1" x 1"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 20

ArmourSorb - 30749915002365 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1/2" x 1/2" (13 mm x 13 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

Americot - 40749915000207 Catalog Number :

Device Description : Americot Blue 3/8" x 1"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 20

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