A PLUS INTERNATIONAL INC.

Address:5138 EUCALYPTUS AVE.,CHINO,CA,91710,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

Gauze/Sponge, Internal, X-Ray Detectable (GDY) (4) Gauze/Sponge, Internal (EFQ) (1)

Premarket Exempt

No Yes

Clear

A Plus - 00683534860243 Catalog Number : GZ-8416-6S

Device Description : 8"X4", 16 Ply, Banded 10’S, X-Ray (Single Straight), Stream Pretreated, Type Vii 8"X4", 16 Ply, Banded 10’S, X-Ray (Single Straight), Stream Pretreated, Type Vii, Bleached White, 200 Pc(s)/Bag, 2000 Pc(s)/Case

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 1

A Plus - 00683534870020 Catalog Number : SP-0251-6S

Device Description : A PLUS - Specialty Sponges , 9/16", Bleached White , Kittner, X-Ray Detectable, A PLUS - Specialty Sponges , 9/16", Bleached White , Kittner, X-Ray Detectable, Steam Pretreatment, 100 Pc(s)/Bag, 1000 Pc(s)/Case

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 1

A Plus - 00683534870044 Catalog Number : SP-1000-6S

Device Description : A PLUS - Specialty Sponges , 1", Bleached White, Round Stick, X-Ray Detectable, A PLUS - Specialty Sponges , 1", Bleached White, Round Stick, X-Ray Detectable, Steam Pretreatment, 100 Pc(s)/Bag, 1000 Pc(s)/Case

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 1

A Plus - 00683534870068 Catalog Number : SP-1501-6S

Device Description : A PLUS - Specialty Sponges , 1.5", Bleached White, Flat Stick, X-Ray Detectable, A PLUS - Specialty Sponges , 1.5", Bleached White, Flat Stick, X-Ray Detectable, Steam Pretreat, 100 Pc(s)/Bag, 1000 Pc(s)/Case

Device Class : 1

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : No

Device Count : 1

A Plus - 00683534870082 Catalog Number : KB-4541-6S

Device Description : Conforming Sponges & Bandage Rolls , Conforming Bandage Roll, 4.5"X4.1 Yard, 6 P Conforming Sponges & Bandage Rolls , Conforming Bandage Roll, 4.5"X4.1 Yard, 6 Ply, Steam Treated, Bulk , 10 Rolls/Bag, 100 Rolls/Case

Device Class : U

Duns Number: 191705904

Premarket Exempt : Yes

Product Code : EFQ

Prescription Use : No

Device Count : 1

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