IMPLANTECH ASSOCIATES, INC.

Address:6025 NICOLLE ST., SUITE B,Ventura,CA,93003,US

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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

Elastomer, Silicone, For Scar Management (MDA) (4)

Premarket Exempt

No Yes

Clear

Gelzone Wrap - M724WRAP4241 Catalog Number : WRAP-424

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP4401 Catalog Number : WRAP-440

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP6481 Catalog Number : WRAP-648

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP648NL1 Catalog Number : WRAP-648-NL

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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