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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

Tape And Bandage, Adhesive (KGX) (7) Dilator, Nasal (LWF) (1) Gauze / Sponge,Nonresorbable For External Use (NAB) (1) Test, Luteinizing Hormone (Lh), Over The Counter (NGE) (1)

Premarket Exempt

No Yes

Clear

Assured - 00639277079596 Catalog Number :

Device Description : Rolled Gauze, 3 in x 2.5 yds (7.6 cm x 2.29 m) unstretched

Device Class : 1

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

Assured - 00639277079633 Catalog Number :

Device Description : Fabric Bandages, 3/4 in x 3 in (1.9 cm x 7.6 cm)

Device Class :

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 30

Assured - 00639277082244 Catalog Number :

Device Description : Sheer Antibacterial Bandages, 3/4 in x 3 in (1.9 cm x 7.6 cm)

Device Class :

Duns Number: 610322518

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 40

Assured - 00639277082275 Catalog Number :

Device Description : Nasal Strips

Device Class :

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : LWF

Prescription Use : No

Device Count : 6

Assured - 00639277152787 Catalog Number :

Device Description : Fabric Bandages, Knuckle and Fingertip, 1 1/2 in x 3 in (3.8 cm x 7.6 cm); 1 3/4 Fabric Bandages, Knuckle and Fingertip, 1 1/2 in x 3 in (3.8 cm x 7.6 cm); 1 3/4 in x 2 in (4.4 cm x 5.0 cm)

Device Class :

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 20

Assured - 00639277182845 Catalog Number :

Device Description : Waterproof Bandages, 3/4 in x 3 in (1.9 cm x 7.6 cm)

Device Class :

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 25

Assured - 00639277182883 Catalog Number :

Device Description : Dressing Bandages, 2 in x 3 in (5.1 cm x 7.6 cm)

Device Class :

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 6

Assured - 00639277230690 Catalog Number :

Device Description : Colored Bandages, 3/4 in x 3 in (1.9 cm x 7.6 cm)

Device Class :

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 30

Assured - 00639277232540 Catalog Number :

Device Description : Sheer Bandages, assorted sizes, 3/4 in 3 in (1.9 cm x 7.6 cm); 3/4 in x 1 1/2 in Sheer Bandages, assorted sizes, 3/4 in 3 in (1.9 cm x 7.6 cm); 3/4 in x 1 1/2 in (1.9 cm x 3.8 cm); 1/3 in x 1 1/2 in (0.8 cm x 3.8 cm)

Device Class :

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 80

Assured - 00639277288882 Catalog Number :

Device Class : 1

Duns Number: 610322518

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 1

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