ROSEMONT VENTURES, INC.

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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) (6) Gauze / Sponge,Nonresorbable For External Use (NAB) (2) Bandage, Elastic (FQM) (1)

Premarket Exempt

Yes

Clear

ALL TERRAIN - 00608503050005 Catalog Number :

Device Description : Advanced Bandages, all one size, 2 3/4 in x 3 1/2 in (70 mm x 89 mm)

Device Class :

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 7

ALL TERRAIN - 00608503050012 Catalog Number :

Device Description : Kids Advanced Bandages, assorted sizes, 5- 1 1/8 in x 2 5/8 in (28 mm x 67 mm), Kids Advanced Bandages, assorted sizes, 5- 1 1/8 in x 2 5/8 in (28 mm x 67 mm), 10- 7/8 in x 2 3/4 in (22mm x 69 mm), 5- 5/8 in x 2 1/4 in (15 mm x 57 mm)

Device Class :

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 20

ALL TERRAIN - 00608503050036 Catalog Number :

Device Description : Fabric Bandages, assorted sizes, 5- 3 in x 1 in (76 mm x 25 mm), 10- 3 in x 3/ Fabric Bandages, assorted sizes, 5- 3 in x 1 in (76 mm x 25 mm), 10- 3 in x 3/4 in (76 mm x 19 mm), 10- 2 1/4 in x 5/8 in (57 mm x 15 mm)

Device Class :

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 30

ALL TERRAIN - 00608503050043 Catalog Number :

Device Description : Sheer Bandages, all one size, 3 in x 3/4 in (76 mm x 19 mm)

Device Class :

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 40

ALL TERRAIN - 00608503050050 Catalog Number :

Device Description : Super-Stick Bandages, all one size, 3 1/4 in x 1 in (82 mm x 25 mm)

Device Class :

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 20

ALL TERRAIN - 00608503050067 Catalog Number :

Device Description : Waterproof Bandages, all one size, 3 1/4 in x 1 in (82 mm x 25 mm)

Device Class :

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 20

ALL TERRAIN - 00608503050074 Catalog Number :

Device Description : Gauze Pads, 2 in x 2 in (50 mm x 50 mm)

Device Class :

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 10

ALL TERRAIN - 00608503050081 Catalog Number :

Device Description : Rolled Gauze, 1 roll, 3 in x 2.5 yds. (76 mm x 2.28 m) unstretched

Device Class : 1

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

ALL TERRAIN - 00608503050098 Catalog Number :

Device Description : Self-Stick Tape, 1 roll, 2 in x 5 yds. (50 mm x 4.5 m) stretched, 2 in x 2.2 yds Self-Stick Tape, 1 roll, 2 in x 5 yds. (50 mm x 4.5 m) stretched, 2 in x 2.2 yds. (50 mm x 2 m) unstretched

Device Class : 1

Duns Number: 933509465

Premarket Exempt : Yes

Product Code : FQM

Prescription Use : No

Device Count : 1

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