Neo G USA Inc

Address:350 Hiatt Drive,Palm Beach Gardens,FL,33418,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

Dressing, Wound, Hydrophilic (NAC) (3) Dressing, Wound, Hydrogel Without Drug And/Or Biologic (NAE) (2) Dressing, Wound, Occlusive (NAD) (2) Elastomer, Silicone, For Scar Management (MDA) (2) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

Yes

Clear

Optiheal Silicone Foam Absorbent Dressing - 00819333029011 Catalog Number : AW001

Device Description : Silicone Foam Absorbent Dressing 4x4in / 10x10cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Optiheal Silicone Postsurgical Dressing - 00819333029028 Catalog Number : AW002

Device Description : Silicone Postsurgical Dressing 8x4in / 20x10cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Optiheal Silicone Multi Purpose Dressing - 00819333029035 Catalog Number : AW003

Device Description : Silicone Multi Purpose Dressing 4x4in / 10x10cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Optiheal Soft Silicone Tape - 00819333029042 Catalog Number : AW004

Device Description : Soft Silicone Tape 25m

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Optiheal Silicone Wound Recovery Strips - 00819333029059 Catalog Number : AW005

Device Description : Silicone Wound Recovery Strips 1.6x6in / 4.1x15.2cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

Optiheal Ultra Thin Absorbent Film - 00819333029066 Catalog Number : AW006

Device Description : Ultra Thin Absorbent Film 4x4in / 10x10cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Optiheal Hydration Multi Purpose Dressing - 00819333029073 Catalog Number : AW007

Device Description : Hydration Multi Purpose Dressing 4x4in, 10x10cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Optiheal Hydration Multi Purpose Dressing - 05060247393070 Catalog Number : AW007

Device Description : Hydration Multi Purpose Dressing

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Optiheal Ultra Thin Absorbent Film - 05060247394060 Catalog Number : AW006

Device Description : Ultra Thin Absorbent Film 4x4in / 10x10cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Optiheal Silicone Wound Recovery Strips - 05060247395050 Catalog Number : AW005

Device Description : Silicone Wound Recovery Strips 1.6x6in / 4.1x15.2cm

Device Class : 1

Duns Number: 079218498

Premarket Exempt : Yes

Product Code : MDA

Prescription Use : No

Device Count : 1

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