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) (8) Cotton, Roll (EFN) (1) Sponge, Ophthalmic (HOZ) (1)

Premarket Exempt

No Yes

Clear

ArmourSorb - 20749915002382 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1/2" x 1 1/2" (13 mm x 38 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

ArmourSorb - 20749915002399 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1/2" x 3" (13 mm x 76 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

ArmourSorb - 20749915002405 Catalog Number :

Device Description : ArmourSorb Ray-Cot 3/4" x 3/4" (19 mm x 19 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

ArmourSorb - 20749915002412 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1" x 1" (25 mm x 25 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

ArmourSorb - 20749915002429 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1" x 3" (25 mm x 76 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

ArmourSorb - 20749915002436 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1 1/2" x 1 1/2" (38 mm x 38 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

ArmourSorb - 20749915002443 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1/4" x 1 1/2" (6 mm x 38 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

ArmourSorb - 20749915002450 Catalog Number :

Device Description : ArmourSorb Ray-Cot 1/2" x 2" (13 mm x 51 mm)

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : HBA

Prescription Use : No

Device Count : 15

Cylindrical Sponge - 20749915002481 Catalog Number :

Device Description : Cylindrical Sponges-Strung 3/8" x 3/4"

Device Class :

Duns Number: 151054954

Premarket Exempt : No

Product Code : EFN

Prescription Use : No

Device Count : 50

Ophthalmic Pledget - 20749915002528 Catalog Number :

Device Description : Ophthalmic Pledget

Device Class :

Duns Number: 151054954

Premarket Exempt : Yes

Product Code : HOZ

Prescription Use : No

Device Count : 20

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